Events

Safety Alert for physio-control lifepak 1000 defibrillators

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
    2017-01-16
  • Event Date Posted
    2017-01-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170116.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 defibrillators the united states food and drug administration (fda) has posted a medical device safety alert concerning lifepak 1000 defibrillator, manufactured by physio-control. the manufacturer announced that they are launching a voluntary field action for the lifepak 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. the manufacturer has received 34 reports where customers have attempted to use their lifepak 1000 defibrillator and the device has shut down unexpectedly due to an intermittent connection between the battery and device electrical contacts. a defibrillator in this scenario may not be able to deliver therapy during a resuscitation attempt, which may expose patients to the risk of serious harm or death. the manufacturer is aware of 8 adverse events related to this issue. the manufacturer has determined that this intermittent connection is a result of wear and subsequent oxidation formation between the battery and device electrical contacts. this condition can occur over time in lifepak 1000 devices that are exposed to vibration and have a battery installed for long periods of time. this issue can potentially affect any lifepak 1000 device, however customers with non-rechargeable batteries who do not routinely remove the battery for inspection, as indicated in the lifepak 1000 defibrillator operating instructions, are more susceptible to this issue. the manufacturer is contacting customers and advising them to immediately remove and reinstall the battery from their device(s). customers are also being advised to implement a weekly schedule of battery removal and reinstallation for all lifepak 1000 devices. the removal and reinstallation of the battery will clean the contacts of oxidation and will reduce the likelihood of this issue from occurring. the manufacturer will be initiating a hardware device correction for all affected lifepak 1000 devices and they will contact customers to schedule device corrections once the hardware correction is ready for implementation. for details, please refer to the fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm537116.Htm http://www.Fda.Gov/safety/recalls/ucm537114.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 january 2017.

Device

physio-control lifepak 1000 defibrillators

Manufacturer

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