Events

Recall of Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter

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
    57563
  • Event Risk Class
    Class 2
  • Event Number
    Z-1548-2011
  • Event Initiated Date
    2010-10-01
  • Event Date Posted
    2011-03-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96630
  • 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 defibrillators (non-wearable) - Product Code MKJ
  • Reason
    L1fepak 12 operating instructions that describe the process for disconnecting the device from ac (wall) power are not always being followed. when the instructions are not followed and the power on button is pushed within 2 seconds after disconnecting the device from ac power, the service indicator will illuminate and the device may fail to charge the defibrillator and/or initiate pacing.
  • Action
    Physio Control, Inc. began mailing the URGENT-MEDICAL DEVICE INFORMATION letter to their consignees on October 1, 2010. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were advised to follow the current LIFEPAK 12 Operating Instructions-Section 7.5-AC Power Adapter Operation and wait at least 2 seconds to push the Power ON button after disconnecting the device from AC power. If the instructions are not followed and the Power ON button is pushed within 2 seconds after disconnecting the device from AC power and the service indicator illuminates, it's important to be aware that turning the device off, then back on again, will reset the device and restore full functionality. The complete copy of the current LIFEPAK 12 Operating Instructions can be downloaded from the company's website at www.physio-control.com/products/ defibrillators, Select LIFEPAK 12, Select Documents. The consignees can call the firm's Technical Support Team at 1-800-442-1142, option 5, between 6:00 A.M. to 4:00 P.M. (Pacific), Monday - Friday.

Device

Device Recall LIFEPAK 12 Defibrillator/MonitorAC Power Adapter
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA and the countries of ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.Devices were distributed to the following countries: ARGENTINA, AUSTRALIA, BAHRAIN, BERMUDA, BOLIVIA, BRAZIL, BRUNEI, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, COSTA RICA, EGYPT, GERMANY, GREECE, HONG KONG, INDIA, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, LEBANON, MALAYSIA, MALTA, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, OMAN, PAKISTAN, PERU, PHILIPPINES, POLAND, PUERTO RICO, QATAR, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, THAILAND, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UAE, UNITED KINGDOM, URUGUAY, VENEZUELA, YEMEN, and ZIMBABWE.
  • Product Description
    The LIFEPAK12 Defibrillator/Monitor. || The LIFEPAK12 Defibrillator/Monitor can be used in AED mode, manual mode or advisory mode. In AED mode, the LIFEPAK 12 is intended for use by personnel who are authorized by a physician/medical director. In manual mode, the operator determines whether or not a defibrillation shock is needed by looking at the ECG rhythm display. Advisory mode can be useful during monitoring; CPSS (Continuous Patient Surveillance System) runs in the background and alerts the operator when a shockable rhythm is detected.
  • 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