Events

Safety Alert for physio-control lifepak cr plus and lifepak express automated external defibrillators

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Physio-Control Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-07-06
  • Event Date Posted
    2016-07-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160706.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: physio-control lifepak cr plus and lifepak express automated external defibrillators the food and drug administration (fda) of the united states posted a medical device safety alert concerning lifepak cr plus and lifepak express automated external defibrillators (aed), manufactured by physio-control inc. the affected aeds may fail to initiate voice prompts when the on/off button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. according to the manufacturer, a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. for details, please refer to the fda enforcement report website: http://www.Accessdata.Fda.Gov/scripts/ires/index.Cfm (recall number: z-2100-2016) if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 july 2016.

Device

physio-control lifepak cr plus and lifepak express automated external defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS Automated External Defibrillators
  • Manufacturer
    Physio-Control Inc

Manufacturer

Physio-Control Inc
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH