Events

Recall of Device Recall LIFEPAK 20 defibrillator

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
    60202
  • Event Risk Class
    Class 2
  • Event Number
    Z-0185-2012
  • Event Initiated Date
    2008-12-30
  • Event Date Posted
    2011-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104736
  • 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
    Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
  • Reason
    When users do not disconnect the test plug and reconnect the quik-combo electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.
  • Action
    Physio Control sent a " Urgent Medial Device Safety Alert" letter dated January 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter instructed the customers to follow the Operating Instructions for AED and Manual Defibrillation mode (Section 4-Therapy, pages 58 and 61) that instructs users to "Connect therapy electrodes to the therapy cable and confirm cable connection to the defibrillator" to prevent users from mistakenly leaving the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. Recommendations to users who use a Therapy Cable: -Disconnect the QUIK-COMBO test plug prior to patient use -Confirm therapy electrodes - to - therapy cable connection -Confirm therapy cable - to - defibrillator connection -Confirm therapy electrodes - to - patient connection Adding 2005 American Heart Association software that includes audible and visual prompts to LIFEPAK 20 defibrillators manufactured prior to January 2007 is optional and not required. If the customers would like to have this optional kit installed in your defibrillators, please contact Physio Control, Inc. Customers can call Technical Support at 1-800-442-1142 for any questions about this recall or or visit our website at www.physio-control notices.com/LP20testplug.

Device

Device Recall LIFEPAK 20 defibrillator
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA ( nationwide ) and the countries of Bahrain, Lebanon , Cyprus, Netherlands, Egypt, Pakistan, Germany, Saudi Arabia, India, South Africa, Iran, Syria, Israel, Turkey, Jordan, UAE,Kuwait, Yemen, Asia Pacific, Australia, New Caledonia, Guam, New Zealand, Hong Kong, Latin America, Anguilla, Jamaica, Argentina, Mexico, Bahamas, Nicaragua, Brazil, Panama, Chile, Peru, Colombia, Trinidad, Costa Rica, Uruguay, El Salvador, Venezuela, Guatemala, Virgin Islands and Canada.
  • Product Description
    The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. || Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 || thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.
  • 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