Events

Safety Alert for Physio-Control LIFEPAK 15 Monitor/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
    2017-02-10
  • Event Date Posted
    2017-02-10
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170210.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 15 monitor/defibrillator the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 15 monitor/defibrillator, manufactured by physio-control, with manufacturing dates from 3 september 2014 to 30 june 2016 and distribution dates from 13 september 2014 to 4 july 2016. the manufacturer is recalling the lifepak 15 monitor/defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. if the electrical shock is not delivered, the monitor will indicate “abnormal energy delivery” on the display. a delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death. for details, please refer to the following websites: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm540979.Htm http://www.Physio-control.Com/workarea/downloadasset.Aspx?id=2147498478 according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 february 2017.

Device

Physio-Control LIFEPAK 15 Monitor/Defibrillator

Manufacturer

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