Events

Safety Alert for Physio-Control LIFEPAK 1000 Defibrillator

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

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
    2014-06-06
  • Event Date Posted
    2014-06-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140606.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 1000 defibrillator the united states food and drug administration (fda) has issued a medical device safety alert concerning lifepak 1000 defibrillator [affected battery part number: 320371500xxx], manufactured by physio-control, inc. the manufacturer has become aware of incidents where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to a very low battery. a defibrillator in this scenario has the potential to fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated. a software malfunction in the lifepak 1000 defibrillator causes the readiness display panel to incorrectly indicate a low battery charge when the battery is actually in a very low charged state and in need of replacing. the manufacturer advises users that batteries at both low battery charge and very low battery charge must be replaced with a fully charged battery, whether or not the "ok" symbol is present. users should always carry a spare fully-charged battery, as stated in the operating instructions. the manufacturer continues to investigate this issue and will have a follow up communication with users regarding this issue. this communication may include updates to operating instructions, software updates or additional maintenance instructions. according to the local supplier, the affected products were distributed in hong kong. for details, please refer to the following fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1660-2014&w=06042014&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 06 june 2014.

Device

Physio-Control LIFEPAK 1000 Defibrillator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Physio-Control LIFEPAK 1000 Defibrillator
  • Manufacturer
    Physio-Control

Manufacturer

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