Events

Recall of Device Recall LIFEPAK Express AED

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Physio Control, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    49056
  • Event Risk Class
    Class 2
  • Event Number
    Z-0150-2009
  • Event Initiated Date
    2008-07-24
  • Event Date Posted
    2008-10-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72640
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Automated External Defibrillator - Product Code MKJ
  • Reason
    The device may not power on although it indicates it is ready for use and would not be able to provide defibrillation therapy.
  • Action
    On 07/24/08, the firm sent an "URGENT MEDICAL DEVICE RECALL" letter with a confirmation sheet via certified return receipt to customers. The letter notified the customer of the recall and the hazard associated with the recall and provided instructions to customers: 1) Immediately verify the AED powers on and voice prompts begin. After verification, press and hold the On/Off button for approximately two seconds to turn the AED off. 2) Keep the AED in use and perform monthly inspections that include the additional AED power on test. Perform a monthly inspection which is consistent with the device labeling. 3) If "OK" is visible on the Readiness Display and AED powers on, it is ready for use. 4) If, at any time, the AED does not power on or if any other indicator displays (i.e. battery or CHARGE-PAK symbol, attention symbol or wrench symbol) immediately call Physio-Control Technical Support (1-800-442-1142). The letter advises customers a Physio-Control representative will contact them within 60 days to arrange a replacement. A confirmation sheet was sent with the letter; to be returned to Physio-Control, Inc. For specific questions or additional information, contact Physio-Control, Inc. at 1-800-442-1142 weekdays between 6:00 a.m. and 4:00 p.m. (PST) or at www.physio-control.com.

Device

Device Recall LIFEPAK Express AED
  • Model / Serial
    PART NUMBER: 3202177-000, 3202177-001, 3202177-002, 3202177-006, 3202177-024, 3202177-026, 3202177-046, 3202177-066, 3202177-080, 3202177-086, and 3202177-106; SERIAL NUMBER: 35057999, 35558399, 35057996, 35076760, 35086872, 35086873, 35086874, 35086875, 35086876, 35086877, 35086878, 35086879, 35086880, 35086881, 35087002, 35087003, 35087004, 35112123, 35120681, 35120682, 35120683, 35174476, 35174477, 35174478, 35174479, 35174487, 35189989, 35190004, 35190371, 35190372, 35237901, 35363559, 35388553, 35415805, 35457181, 35606013, 35627387, 35667618, 35702342, 35843530, 36084979, 36106000, 35086839, 35142569, 35142570, 35142571, 35142572, 35142573, 35142574, 35266844, 35266845, 35266878, 35266879, 35266881, 35266883, 35266884, 35266886, 35266887, 35266888, 35266889, 35266890, 35266891, 35266892, 35266893, 35266899, 35266900, 35314291, 35416139, 35450316, 35450324, 35058947, 35058948, 35058949, 35058950, 35058951, 35058952, 35058953, 35058954, 35058956, 35058958, 35058961, 35058968, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide including USA (and Puerto Rico) and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada , Chile, Colombia, Dominica, Germany, Hong Kong, Hungary, Jamaica, Japan, Mexico, Netherlands, New Zealand, Singapore, Uruguay, Venezuela, and Virgin Islands.
  • Product Description
    LIFEPAK Express Automated External Defibrillator (AED). Labeling on the device states LIFEPAK CR Plus/LIFEPAK EXPRESS Defibrillators with ADAPTIV Biphasic Technology; Medtronic Emergency Response Systems, Inc. 11811 Willows Road NE Redmond, WA. The battery operated, small portable device is primarily deployed in Public Access Defibrillator (PAD) environments where the expected use for any one device is once every 20 months. Product is capable of 30 full discharges. || LIFEPAK Express AEDs are intended for use on victims/patients in cardiac arrest. It includes a patented shock advisory system that notifies the user (i.e. minimally trained responder) if it detects a cardiac rhythm that requires a shock. The individual must be unresponsive (unconscious), not breathing normally, and showing no signs of circulation (for example, no pulse, no coughing, or no movement). With Infant/Child Reduced Energy Defibrillation Electrodes, the LIFEPAK Express AEDs may be used on children who are up to 8 years old or who weigh up to 25kg (55 lb). The device is designed specifically for infrequent use and for use by people whose only training is in CPR and in using AEDs.
  • Manufacturer
    Physio Control, Inc.

Manufacturer

Physio Control, Inc.
  • Manufacturer Address
    Physio Control, Inc., 11811 Willows Rd Ne, Redmond WA 98052-2003
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA