A: Yes. Order replacement batteries and pads for your Philips HeartStart AED. Or, Fax: 1 (833) 371-1011 42172105. Instructions for Downloading Viewers and Players. A:Philips is working on design changes intended to eliminate the issue in the MS071A and MS072A pads. Nearly90%of out-of-hospital cardiac arrests are fatal. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. We have received your form request. Pre-owned AEDs are a great alternative to new devices for customers on a tight budget. A:Yes. Voluntary Recall of Philips Automated External Defibrillators Due to this situation, Onsite AEDs are not available. HeartStart FRx: US - CA, CT, FL, IL, MO, NY,TN, TX and WI OUS . Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Onsite Instructions for Use Onsite Quick Reference Guide Onsite Supplemental Information Sheet HS1 Technical Reference Manual HS1 Technical Reference Manual Onsite Instructions for Use: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=12324298&objAction=Open Onsite Quick Reference Guide: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=811095&objAction=Open Onsite Supplemental Information Sheet: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=9996491&objAction=Open, Onsite Instructions for Use Onsite Quick Reference Guide, Onsite Instructions for Use: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=12324298&objAction=Open, Onsite Quick Reference Guide: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=811095&objAction=Open, Onsite Supplemental Information Sheet: http://incenter.medical.philips.com/doclib/getDoc.aspx?func=ll&objId=9996491&objAction=Open, MSDS Onsite AED (M5066A, HS1) MSDS Onsite Primary Battery (M5070A), Home Instructions for Use Home Quick Reference Guide Home Supplemental Information Sheet, MSDS Home AED (M5068A, HS1) MSDS Home Primary Battery (M5070A). AED recall | Philips Confirmation as to whether the device contains the resistor at issue can be done by contacting the firm. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. A:Philips shipments of new pads could still experience the issue described in the Medical Device Correction/Field Service Notice. AEDSuperstore offers a variety of FDA-approved AED options for your business type or location. The devices may continue to be used. To request a warranty exchange unit or a trade-in rebate, or to obtain additional information, contact your local Philips representative. Q:Is Philips fulfilling orders for MS071A and MS072A pads cartridges? In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDS after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. Quantity in Commerce. If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. A:No matter the state of the pads, the HSl/OnSite/Home AED voice prompts will audibly guide the user through each step of the procedure; therefore, Philips is not planning to supply any new labeling instructions to be put on the device or inside its carry case. If your AED was produced in 2013 and the fourth digit in its serial number is the letter C or later (D, E, F), it is not covered by this recall. Note: If you need help accessing information in different file formats, see The recall was expanded to notify customers who received an HS1/OnSite/Home AED more than 10 years ago. Customers were not notified of previous recalls associated with various defibrillator models. Heart attacks are often mistaken with SCA, which may result in a lack of awareness of its devastating effect on people of all ages. This consent decree concerns required quality system improvements at the company's defibrillator manufacturing facilities in Andover, Massachusetts, and Bothell, Washington. These Philips AEDs have a low failure rate of less than % per year. Please make a note of the Serial Number(s) of your HSl/OnSite/Home AED(s) and contact Philips. What the problem is and under what circumstances it can occur 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. AEDs are designed to be updated. 3. If a device is covered by this notification and is still under warranty, you may optionally receive a refurbished exchange unit at no cost. A: Customers who received the Medical Device Correction notice should read and understand the instructions provided in the letter, fill out and return the Reply Form. Selected products The issue described in the Medical Device Correction/Field Safety Notice has not been a contributing factor in pads fulfillment timelines. Koninklijke Philips N.V., 2004 - 2023. HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation . Affected AEDs are not recommended to be removed from service. This page will be updated with timing expectations as they are made available. The SMART pads cartridge will be released. AED Pads Medical Device Correction Notice | Philips Phillips / Field Action for R92 Resistor Issue | Think Safe A:Philips monitors the performance of medical products used by customers worldwide. Check your Philips HeartStart AED batteries and pads todaybefore help is needed. AED.us provides a variety of AED models from the Philips HeartStart brand. What is a Recall? Lightweight at 3.3 pounds. However, so as not to increase the number of AEDs in use that depend on M5071A and M5072A pads, Philips has stopped fulfillment of new HSl/OnSite/Home AEDs. Physio Control Medtronic / Recalls Defibrillation Electrodes Due to Incorrect Placement Instructions for Infants Depicted on Artwork, Phillips / HeartStart MRx Defibrillators Recall, Advanced Life Support (ALS) Equipment & Accessories, Automated External Defibrillators (AEDs), Accessories & Packages, CPR Technology & Emergency Oxygen Equipment, Personal Protective Equipment, BBP & Sharps, Responder, Trauma, Active Violence & Severe Bleed Kits, Self-contained Emergency Treatment (SET) System, Emergency Alerting & Communication Software, First Voice Medical Direction / Oversight, CUSTOMIZED & WHITE LABEL SOFTWARE SOLUTIONS, EMERGENCY MANAGEMENT MOBILE APPLICATION (EMMA), OSHA BEST PRACTICE CPR, AED, FIRST AID PROGRAMS, 48 Packs of Germisept Multi-Purpose Wipes, 50-Pack PPE Kit w/ Purchase of Two (2) AEDs, First Voice Training for 30 w/ Train-the-Trainer with Purchase of Three (3) AEDs, 1-Year Subscription to E.M.M.A (Emergency Management Mobile Application) w/ Purchase of Two (2) AEDs, 1-Year of First Voice Manager Compliance Software, 2-Years of Remote Monitoring Cellular Service, HeartSine Samaritan AED Defibrillator with Purchase of 3,000 Packs, 50-Pack PPE Kit with Purchase of 2,016 Packs, First Voice Training for 30 w/ Train-the-Trainer with Purchase of 1,104 Packs, 1-Year Subscription to E.M.M.A. You can learn more on Philips website. The recall is in addition to a previous notice first sent in 2012 that indicated an electric component (a resistor) in the device may fail.</p><p><br></p><p>The failure causes the . A:No, the issue described in the Medical Device Correction/Field Service Notice does not affect the FRx device and pads. A:Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. 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. Q:Should I remove from service my HSl/OnSite/Home AED due to this issue? Q:Why does Philips plan to supply, free of charge, one Adult pad for every HSl/OnSite/Home AED shipped in the preceding 10 years? In the USA, customers may call Philips at (800) 263-3342. , Maintaining the HeartStart HS1/OnSite/Home Pads and Battery, Maintaining the HeartStart FRx Pads and Battery. This notification is intended to inform you about: 1. Read more. Affected serial numbers for Model # M5066A: The devices may continue to be used. US - CA, CT, FL, IL, MO, NY,TN, TX and WI US Nationwide including Puerto Rico and Guam, Germany, Australia, Sweden, Japan, Canada, Taiwan, France, Netherlands, Spain, Singapore, Austria, South Africa, Italy, United Kingdom, India, Malaysia, Switzerland, Chile, Ireland, Norway, Hong Kong, Argentina, Mexico, Bolivia, Croatia, French Guiana, Denmark, United Arab Emirates, Hungary, Belgium, Indonesia, Korea, Republic of, Bhutan, New Zealand, Bulgaria, Mauritius, Trinidad and Tobago, Israel, Guatemala, Mali, Algeria, Philippines, Malta, Curacao, Panama, Paraguay, Costa Rica, Colombia, Liechtenstein, Saudi Arabia, Monaco, Estonia, Senegal, Reunion, Luxembourg, Qatar, El Salvador, Namibia, Myanmar, Nigeria, Poland, Aruba, Greece, Martinique, Guadeloupe, Dominican Republic, China, Kosovo, Portugal, Bangladesh, Tanzania, Peru, Lithuania, New Caledonia, State of Palestine, Finland, Cambodia, Macao, Cyprus, Zambia, Viet Nam, Uruguay, Ecuador, Netherlands Antilles, Czech Republic, French Polynesia, Kenya, Cameroon, Guinea, Mayotte, and Brunei Darussalam. Features. Klik her for vigtige oplysninger om sikkerhedsnoten vedrrende nogle Philips Respironics CPAP, BiPAP og ventilation. A:If you have taken permanently taken your HSl/OnSite/Home AED outof service, please make a note of the Serial Number(s) of the HSl/OnSite/Home AED(s) that were taken out of service if available, and contact Philips. Copyright 2020 AEDUSA. The letter identified the product, the problem, and the action to be taken by the customer. Philips AEDs include automated self-tests that run even when the device is not in use. Q: Why is Philips sending this Medical Device Correction/Field Service Notice letter now? In some cases, a device within the date range covered by the notification did not contain a resistor previously associated with a failure. A:Philips is working on changes intended to eliminate the issue in the M5071A and M5072A pads, including updates to production processes and changes to the pad composition. If an AED has ever emitted or begins to emit a pattern of triple chirps, call Philips customer service at 1-800-263-3342 in the United States or contact your local Philips representative. Q:How and when will I receive an updated M5071A Adult SMART Pads Cartridge? HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED (2021-03-03). A Philips representative will reach out to you to help you identify any affected AED. We are always interested in engaging with you. Dont let your AED become out of date from American Heart Association (AHA) guidelines. Class 2 Device Recall Philips, HeartStart FRx Defibrillator This article explains the 2018 Philips AED recall and includes the February 2022 electrode pads recall to answer all your questions. Q:How and when will I receive an updated M5072A Infant/Child SMART Pads Cartridge? After it has been confirmed that you have an affected AED and a replacement Philips AED has been sent to you, please return the affected AED to Philips using the shipping label to be . It will not ship until available. If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. You must respond to receive any free-of-charge updated Adult pads cartridges. HeartStart AEDs | Philips Lift out the used SMART pads cartridge. The devices may continue to be used. Designed for the ordinary person in the extraordinary moment, Philips HeartStart OnSite AED is ready to act and virtually ready to go. Globally, cardiac arrest claimsmore livesthan colorectal cancer, breast cancer, prostate cancer, influenza, pneumonia, auto accidents, HIV, firearms, and house fires combined! By clicking on the link, you will be leaving the official Royal Philips ("Philips") website. A:Yes, Philips continues to fulfill orders for M5071A and M5072A pads cartridges. PDF M5071A(adult)andM5072A(infant/child)padsforusewithHS1/OnSite - Philips Affected AEDs are not recommended to be removed from service. Please contact us for detailed Instructions for Use, Clinical Summaries or the Technical Reference Manual. Class 2 Device Recall Philips, HeartStart FRx Defibrillator. PDF URGENT Medical Device Recall - AED4Life Philips believes that the risk to patient safety of using pads that may experience this issue is lower than using expired pads or having no AED available. The second and third characters in the serial number on the back of the AED indicate the year of manufacture: Home/Onsite: A02I-xxxxx through A13B-xxxxx. Affected AEDs are not recommended to be removed from service. Philips is offering trade-in rebates depending on the age and model of the affected AED. Visit. The serial number for the HeartStart FRx starts with the letter B, followed by 8 numbers and letters. A11K-08837, Each of these rhythms is shockable with an AED unit. 1. 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. If an AED has ever emitted or begins to emit a pattern of triple chirps, please call Philips customer service. A: Yes. A:Owners on file of for each HSl/OnSite/Home AED shipped in the past 10 years are being notified per appropriate country regulations. If an AED has ever emitted or begins to emit a pattern of triple chirps, please call Philips customer service. If a device is covered by this notification and is still under warranty, you may optionally receive a refurbished exchange unit at no cost. MasterColor Ceramic Metal Halide ED-17 Protected. Q:Will new orders M5071A and MS072A be fulfilled with pads that could experience this issue? Foreign distribution was made to the following countries: Canada, Afghanistan, Algeria, Argentina, Aruba, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Brunei Darussalam, Cambodia, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Fiji, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Malaysia, Malta, Mauritius, Mexico, Morocco, Namibia, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Niger, Norway, Oman, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirate, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe. Tests are done every day, weekly, and monthly. 3. The devices may continue to be used. Q:Is Philips fulfilling orders for AEDs? Why is the Onsite AED backordered? International distribution in the countries of Australia, Canada, France, Germany, Japan, Norway, Switzerland. Q:When updated pads are available, will the M5071A and M5072A pads cartridge part numbers change? A07A-01278, For example, did you know that: Every year, 475,000 people die from cardiac arrest in the United States. The OnSite has a clear voice prompt system and "on demand" CPR coaching. Therefore, until updated pads are available, Philips plans to continue fulfilling M5071A and M5072A orders so that customers can replace used or expired pads. A:Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Q:Who can I contact if I have questions? You are about to visit a Philips global content page. Q:Does this issue affect Philips HSl/OnSite/Home AEDs? You will be receiving and email with a link to the PDF. Where Can I Buy HeartStart OnSite AED Automated External Defibrillator? On February 11, 2021, Philips issued a "Urgent - Safety Notification" to affected . Philips makes no representations or warranties of any kind with regard to any third-party websites or the information contained therein. Recalls are an important safety measure that companies rely on to keep the public informed about risks that may exist in their products. The devices may continue to be used. Letters to customers outside of the U.S. were localized in conjunction with the local Philips market organizations and are in progress. 1-800-263-3342 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). Philips is your partner in AED training Learn more about how we can help you manage your AED program through our array of management tools and resources. When updated pads are available, Philips plans to supply, free-of-charge, one M5071A (Adult) pad for every HSl/OnSite/Home AED shipped in the preceding 10 years. On 09/11/2019, the firm sent an "Customer Information Medical Device Recall" notification to customers via Certified Mail informing them that certain models of their Automated External Defibrillator (AED) contain a Printed Circuit Assembly (PCA) manufactured by a supplier that did not follow specific procedures when repairing PCAs that initially failed required testing. A: Yes. Worldwide distribution. Radiography | X-ray & Fluoroscopy Solutions, HeartStart HS1/OnSite/Home and FRx Maintenance Videos, A: Yes. A problem has been identified in certain Philips M5072A HeartStart Infant/Child SMART Pads Cartridges which are used with the Philips HeartStart OnSite and HeartStart Home Automated External Defibrillators (AEDs). It is recommended that customers and users keep their HSl/OnSite/Home AED in service according to the Instructions for Use/Owners Manual and the field safety notice. OUS - Australia, Brazil, Canada, Germany, Italy, Japan, South Korea, Norway, Switzerland and Taiwan. In all of these situations, the gadget gave at least one jolt before failing. Their records indicate that a potentially affected AED was shipped to a customer and the quantity affected, but the records do not, however, contain serial number information. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, Automated external defibrillators (non-wearable), 510(K)s with Product Code = MKJ and Original Applicant = PHILIPS MEDICAL SYSTEMS, Instructions for Downloading Viewers and Players, Class 2 Device Recall Philips HeartStart HS1 Onsite or Home AED, Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063, HeartSmart HS1 OnsiteModel: M5066ASoftware Version: FRx codeRev: E.03.063System Serial Numbers:A18B-01564A18B-05110A15F-00203A15F-00836A16A-05193A18B-01898A18B-04580A18C-06368A18C-13087A14J-05349A17G-04454A16F-05540A16H-00179A16I-05335A15C-06311A18B-01163A14E-01309A14H-00385A14H-03858A14J-06953A15B-02135A15I-00313A15J-02119A15J-03499A16A-00020A16A-04110A16D-02839A16E-00092A16E-00321A16E-01139A16H-01715A16H-03269A16H-03289A16H-03295A16H-03388A16I-01108A16I-01192A16J-03827A16K-09220A16K-09284A16K-09350A16L-08039A17D-02967A17E-06623A17L-05540A18B-06555A16B-01360A16J-04476A16F-05541A16K-06215A17F-05535A17G-01106A18B-05091A16L-03891A18D-00634A14I-05831A14I-06556A14J-04548A15H-01226A15H-04421A16B-05332A16E-01367A16F-01716A16H-01397A16H-02511A16I-01557A16I-01570A16I-01572A16I-01819A16I-01992A16I-02579A16I-03774A16I-08781A16I-09247A16I-09253A16I-09345A16K-02763A17F-01602A17F-02212A17F-07151A17I-06611A17K-05176A17L-12513A17L-13149A17L-13954A17L-14968A18A-00046A18B-12050A18C-12844A18C-13301A18C-13490A18C-15686A18C-16215A18C-16221A18C-16224A18C-16236. All Rights Reserved. AED recall | Philips Philips has become aware that a HeartStart HS1 Home, HS1 OnSite, FRx or FR2/FR2+ AED in customer's possession may have been omitted from one or more previous recalls or customer information notifications. SMART pads will adapt to the defibrillator instructions. A:Yes, Philips continues to fulfill orders for the FRx AED. HeartStart OnSite AED - OnSite Defibrillator | Philips Users should continue to use the HSl/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. It will be formatted like this: B0XX-XXXXX. AED recall | Philips When available, updated pads will be identified by their Lot number. Note: If you need help accessing information in different file formats, see Our site can best be viewed with the latest version of Microsoft Edge, Google Chrome or Firefox. If no spare is available, perform CPR until help arrives. Rebates range from $50 - $625 . Q: Are the AEDs under this recall safe to use? A11K-03264, A06L-01678, 2002-2023 AED Superstore. Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards. Updated pads are expected to eliminate this issue. Philips expects to release updated pads later in 2022, depending on design activities, subcomponent availability, and regulatory approval. either online, by regular mail or by fax. Extend the life of your AED as much as possible through our comprehensive database of AED recalls and updates available (most of which are free). Q:The Medical Device Correction/Field Safety Notice letter states that Philips plans to supply updated pads. The failure rate for Philips AEDs is less than 0.5% per year.