Philips OnSite AED Pads Adult HeartStart Adult SMART Pads are appropriate for cardiac arrest victims weighing 55 pounds (25 kg) or more. Please read the document provided by Philips in regards to the above recall for detailed description and steps . Once you receive the updated Adult SMART pads cartridge, replace the current pads cartridge in your AED with the new one. You are about to visit a Philips global content page. Please complete and submit the additional information once you receive the communication. Easy as 1-2-3: 1 Take out the new SMART Pads cartridge from its package. What the problem is and under what circumstances it can occur Play Using AEDs Replacing HS1/OnSite/Home pads cartridge Watch this video to find out how to set up and maintain your OnSite AED. As affected pads are stored in sealed cartridges, this issue will not be visible until the cartridge is opened for use. No matter the state of the pads, the HS1 AED will audibly prompt the user through each step of the procedure. Philips issued an Emergency Medical Device Correction regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) Any pad currently installed in or stored with an HS1/OnSite/Home AED could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. Philips AED Recall Notification | AED Superstore If the current Adult SMART pads cartridge is not expired, please keep it as a spare to use in an emergency only. When will a correction for this issue be ready? What should I do if I have an HS1 AED but have not heard from Philips or a distributor? problem has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. Quick Overview Adult Replacement Electrode Pads Cartridge for the Philips HeartStart OnSite AED. The SMART pads cartridge will be released. Easy as 1-2-3 We've equipped OnSite with integrated SMART Pads that will provide feedback to the AED so it can adapt its voice instructions to your actions and your pace. or more . Follow These Steps to Replace / Install Your Philips HeartStart OnSite SMART Pads Cartridge. Unexpired M5071A Adult pads cartridges with a LOT number that begins with Y are eligible to be replaced with an updated Adult pads cartridge, free-of-charge. The AED will audibly guide users through each step of the procedure. Please provide a copy of the Field Safety Notice letter with the new owner. What should I do if I have transferred ownership of my HS1 AED? List the Devices on site with serial # and software version Distributed and the actions taken/other relevant details e.g. 2 Slide the latch on the top of the Onsite. PDF This document contains important information for the - Philips To replace your pads, locate the latch at the top edge of the AED and slide it to the side. What should I do if I have permanently taken my HS1/OnSite/Home AED out of service? A problem has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. Lift out the used SMART pads cartridge. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. PDF URGENT Medical Device Recall - AED4Life If I use the AED, can I put the current pads back in for use? There is also the potential for delayed therapy, if the appearanceof the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads. No matter the state of the pads, follow the voice prompts because the AED will walk you through the necessary actions. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. What is the problem? HeartStart Automated External Defibrillators (AED) During use, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. The reason is that it is possible that once applied, your Philips AED pads may have poor adhesion to the skin due to excessive moisture, body hair, or improper pad placement, and your pad will not stick, leaving your AED useless and the patient's life at risk. If this occurs, the HS1 AED could deliver less effective or ineffective therapy. Amazon.com: Philips M5071a Pads Date: March 2, 2022. Replacing your HeartStart AED Pads | Philips Key Points Please complete and submit the additional information once you receive the communication. Philips issued an Emergency Medical Device Notice regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) AED Inspection Tag + $1.99. Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Philips m5071a: HeartStart OnSite AED Pads | AED Market Philips M5071A HeartStart OnSite SMART Adult - AED Superstore What should I do if I am aware of an impacted Philips device in my facility, but I am not the original purchaser? Contact us Technical support: 1-800-263-3342 Email: aedsupport@philips.com AED frequently asked questions AED FAQs Philips HeartStart OnSite Replacement Pads Cartridge - Adult Once Competent Authorities have cleared the updated pad and you have verified your information, the Adult SMART pads will be shipped to the address you indicated. This URGENT Medical Device Recall Letter is intended to inform you about: 1. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. Medical Device Recall on 2022-03-02 for Philips M5071A - AED4Life Philips Heartstart HS1 adult pad M5071A. Any links to third-party websites that may appear on this site are provided only for your convenience and in no way represent any affiliation or endorsement of the information provided on those linked websites. You can learn more on Philips' website. Should I store a spare pads cartridge with my HS1/OnSite/Home AED? Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II. Philips - M5071A HS1 Adult SMART Defibrillator Pads Cartridge 8. In April 2022 Philips notified customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs. There is also the potential for delayed therapy, if the appearanceof the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads. communication. AED Pads Medical Device Correction Notice | Philips Once Competent Authorities clear the updated Adult SMART pads, Philips will provide a complimentary updated Adult SMART Pad cartridge. IMPORTANT NOTE: The issue described in the Field Service Notice does not affect the FRx device and pads. IMPORTANT NOTE: The issue described in the Field Service Notice does not affect the FRx device and pads. All staff was made aware of the required action as stated. Philips has issued notifications to customers of approximately 1 million HeartStart HS1, OnSite, and Home Automated External Defibrillators (AEDs), which are supplied with a total of 1.8 million SMART Pads Cartridges. Your complimentary Adult SMART pads will be provided to you. If this occurs, the HS1 AED could deliver less effective or ineffective therapy. AED Pads Medical Device Correction Notice | Philips At the time of the issuance of the February 2022 notification, Philips has received 100 reports about this issue since 2010 out of approximately 5 million shipments of M5071A and M5072A pads. Replacements are permitted for warranty purposes only If your current pads cartridge has not expired, please keep the current pads cartridge and use it as a spare in case of emergency. . Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. Users should continue to use the HS1 AED and pads as-is and follow the devices voice prompts during use. HeartStart OnSite AED - OnSite Defibrillator | Philips Caution: DO NOT remove the extra set of stored defibrillation pads from the sealed package . Free shipping! As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1/OnSite/Home AED. No, this issue only affects Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1, HeartStart OnSite, and HeartStart Home Automated External Defibrillator (AED) devices. The AED will audibly guide users through each step of the procedure. If you have permanently taken your HS1/OnSite/Home AED out of service, please make a note of the Serial Number(s) of the HS1/OnSite/Home AED(s) that were taken out of service if available and contact Philips or your local Philips Representative. Philips HeartStart AED Defibrillator Replacement Adult Training Pads Philips M5071A Smart Adult Electrode Cartridge for - WebstaurantStore What should customers do if there seems to be something wrong with a pads appearance? Philips or a Philips Distributor will send a letter to the customer of record. It will be formatted like this: A0XX-XXXXX. The foil seal on the pads cartridge should be opened only for patient use in an emergency because the pads will quickly dry out if the foil seal is broken. Philips HeartStart OnSite/Home SMART Pads AED Electrode Pads Affected Products HEARTSTART DEFIBRILLATION PADS Reason A problem has been identified in certain philips m5072a heartstart infant/child smart pads cartridges (lot y111220-01) which are used with the philips heartstart onsite and heartstart home automated external defibrillators (aeds). An Official Philips AED web-store. What should customers or users do? Philips HeartStart OnSite SMART Adult Replacement Cartridge Electrode Pads. Once we have clearance, we will begin providing updated Infant/Child SMART pads. The serial number for HeartStart HS1, HeartStart Onsite and HeartStart Home starts with the letter "A", followed by 8 numbers and letters. Philips - M3501A Adult/ Child Multifunction Defibrillator Pads, AAMI/IEC $274.94 Philips HS1 Adult SMART Pads Cartridge M5071A / 861291 $75.00 Pacific West Medical Does this issue affect the Philips indemnification obligation to users? The Philips M5071A replacement pads have a 2-Year Shelf Life if no rescue is required during that time. How can I order additional Adult SMART pads? Philips HeartStart OnSite SMART Adult Pads | AED.US Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs. If the problem occurs and you do not have a spare pads cartridge, attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive. Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs. Can I use the same Philips HeartStart Replacement pads on multiple patients? The Philips onsite AED pads also come with a built-in handle that is able to be pulled off for quick access. Class 2 Device Recall Philips, HEARTSTART, INFANT/CHILD SMART PADS If changes have been made to the locations of pads in accordance with operations at your facility, make replacements as necessary. These Philips adult AED pads are for use on persons 8 years of age and older or 55 lbs. Heartstart Home Philips Electronics Australia Ltd, in consultation with the Therapeutic Goods Administration, is undertaking a Product Defection Correction to alert users to a possible problem with the AED SMART Pads used with these defibrillators. Philips issued an Emergency Medical Device Correction regarding a potential gel peeling issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite) Part #: M5071A (34) Write a Review Your Price: $75.00 Front Add Ons Infant/Child Electrode Pads $115.00 Spare AED Battery $175.00 AED Check Tag $5.95 Adult TRAINING Cartridge $119.00 ARCH AED Medical Direction $149.99 Qty Add to Cart Add to Wish List Jump To: Overview Customer Reviews Overview In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patients skin. The Pull-handle alllows the rescuer to quickly and easily tear open the pads by just pulling down on marked cartridge handle. AED and Customer Support | Philips Continue using the HS1 AEDand pads as-is, Do not try to examine the pads' gel prior to patient use, Philips recommends that you store a spare pads cartridge with your HS1 AED. Philips OnSite AED Pads Adult - by Philips AED Pads - AED USA The SMART pads cartridge will be released. Should this occur, there is a possibility of insufficient therapy delivery, or of patient skin burns. Once you receive your updated Adult SMART pads cartridge, install it into your HS1/OnSite/Home AED. Affected Stock If you have no affected stock, tick this box: If you have affected stock, please complete the stock details table below. Due to this situation, Onsite AEDs are not available. The relevant regulatory authoritieswere notified of this issue in February 2022. Should they stop using the devices? In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patients skin. Now your AED is ready for use in an emergency. If the Infant/Child SMART Pads Cartridge is still inside the pouch, then it can remain in service until replaced. Once we have clearance, we will begin providing updated Adult SMART pads worldwide. What has Philips done to correct the issue? The current pads cartridge LOT # starts with a Y. Philips has updated the Adult SMART pad and expects to submit for clearance by Competent Authorities worldwide. Philips is working on design changes intended to eliminate the issue in the M5071A and M5072A pads. Add Ons. 9. Philips M5071A HeartStart OnSite Adult SMART Pads - AED Brands Verify your contact and AED information by following instructions on the communication you will be receiving. Lift out the used pads cartridge. Remove a new SMART Pads Cartridge from its package and insert the cartridge into the cartridge well on the front of the HeartStart. DearCustomer, AproblemhasbeenidentifiedinthePhilipsM5071A(adult)andM5072A(infant/child)AEDpadsthatcouldpose ariskforpatientsorusers.ThisURGENTCorrectionisintendedtoinformyouabout: 1.Whattheproblemisandunderwhatcircumstancesitcanoccur This package contains 1 set of M5071A electrode pads. . The HeartStart HS1 AEDs are intended for use in public places or the home. It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. Owners of the HS1/OnSite/Home AEDs who have not received a letter from Philips or a distributor by the end of March 2022 may contact Philips or their local Philips Representative. Philips HeartStart M5071A SMART Pads Cartridge - AEDs, AED Pads, and Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the devices voice prompts during use, because the AED will audibly guide users through each step of the procedure. The system won't announce the next step until you are ready. Keep a copy of your letter with the Instructions for Use/Owners Manual of your HS1 AED. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1/OnSite/Home AED. Philips Healthcare M5071A - McKesson Medical-Surgical At the time of the October 2022 notification update, Philips has received 151 reports about this issue since 2010 out of approximately 5 million shipments of M5071A and M5072A pads. Inquire with a Philips healthcare sales rep, Subscribe for regular news and updates from Philips, Get technical support for a healthcare product, Find product documentation and instructions for use. Other AEDs vary slightly but all Philips AEDs have simple, clear instructions telling you what to do. Includes adult sized resuable adhesive pads and connector to be used with training cartridges ; Replace worn out adult size training pads for use with your AED trainer ; Please contact Philips directly with any questions regarding the performance or operation of your HeartStart Products. The current pads cartridge LOT # starts with a Y. What the problem is and under what circumstances it can occur Philips has an updated Adult SMART pad and expects to submit for clearance by Competent Authorities globally. Philips has issued notifications to customers of approximately 1 million HeartStart HS1, OnSite, and Home Automated External Defibrillators (AEDs), which are supplied with a total of 1.8 million SMART Pads Cartridges. After all replacements are complete, check the quantity of SMART pad cartridges fo r recall. M5071A (adult) and M5072A (infant/child) pads for use with HS1/OnSite/Home AEDs may experience gel separation and reduction of gel surface area. February 2022 Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/OwnersManual. A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay of therapy if the user hesitates to apply the pad due to its appearance. HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The . We are always interested in engaging with you. If your current pads cartridge with a LOT number beginning with Y has not expired, it may be kept with your HS1/OnSite/Home AED as a spare in case of an emergency only. Perform the above steps for all AED that are shown on the Updated Pad Dispatch details (M5071A Adult Pads). PDF Product Defect Correction - Philips Philips Defibrillator Recall | aedusa.com - AED USA Knowledge Philips is issuing a Field Safety Notice regarding the Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A]for use with the HeartStart HS1, Automated External Defibrillator (AED) devices. Philips HeartStart OnSite (HS1) Adult SMART Pads (M5071A) - School Health A short video showing how to replace the pads cartridge can be found at: www.philips.com/replace-aed-pads-video, Locate the latch at the top edge of the AED and slide it to the side. A short video showing how to replace the pads cartridge can be found at: Locate the latch at the top edge of the AED and slide it to the side. Promotion Details * Coupon expires 7/31/23 at 11:59 pm CT. Not valid on past purchases, or in combination with other coupon codes or specialty pricing. Class 2 Device Recall PHILIPS ADULT SMART PADS CARTRIDGE Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite). Prompts are repeated and rephrased if needed and include additional instructions to aid understanding. Product Specifications Features HeartStart Adult SMART Pads are appropriate for cardiac arrest victims weighing 55lbs or more Pads should be replaced after each use, or once every (2) years Cartridge can be easily snapped into the OnSite AED, making replacing your electrodes easier than ever Rating: (1) $75.00. For each rescue, a SMART Pads Cartridge replacement is required. You must respond to receive any. If you have not responded to the request, you will receive a communication shortly asking for some additional information about your HeartStart HS1/OnSite/Home AED(s). Your serial number can be found on the back of your device next to the battery well. www.philips.com/replace-aed-pads-video. PDF M5071A Adult SMART Pad Cartridge Replacement Procedure Form - Philips The Philips Heartstart Onsite AED Defibrillator Adult Replacement SMART Pads Cartridges, Item #M5071A are supplied in a sealed pouch with the connector. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the Urgent Medical Device Correction Letter/Field Safety Notice. Please complete this request as soon as possible. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the voice prompts because the AED will step the user through the necessary actions. In case of trouble, install spare pads if available and continue the rescue. 2004 - 2023 Philips Electronics N.V. ng k Bn quyn. You can view a short video showing how to replace the pads cartridge at the following web address. The notification advises customers that some affected pads may exhibit the gel separation issue. How will I receive my Adult SMART pads cartridge? Each cartridge contains 1 set of electrode pads and has the Philips "pull handle" built in. If you have already responded to the communication sent, there is nothing more you need to do. The notification advises customers that some affected pads may exhibit the gel separation issue. $75 USD Product Code: M5071A ADD TO CART Yes, we have them in stock and ready to ship! 2. Please contact your local Philips representative. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing. Heartstart Defibrillation Pads - Canada.ca Just follow these simple steps: Unlock the old cartridge by sliding the latch on top of the AED; Remove the old pad cartridge and discard; Insert the new Philips HeartStart OnSite replacement pads, m5071a, and snap into place. Are these devices being removed from service? This allows the pads to be stored in a pre-connected state for rapid deployment during an emergency.
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