Events

Field Safety Notices about Cardiac Science’s Powerheart and CardioVive Automated External Defibrillators

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by Cardiac Science.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Number
    SN2012(11)
  • Date
    2012-08-03
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/cardiac-science-s-powerheart-and-cardiovive-automated-external-defibrillators&id=4f7ef825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The cardiac science powerheart and cardiovive aeds affected by two separate issues may not deliver therapy.
  • Action
    1. Ensure that the relevant personnel in your organisation are made aware of the two issues.  2. Determine if you have purchased a device that is affected by either of the above issues by reviewing the attached FSNs and lists of affected AED model numbers and serial numbers.  3. If you have an affected device, please follow the instructions provided by Cardiac Science in the relevant FSN.

Device

Cardiac Science’s Powerheart and CardioVive Automated External Defibrillators

Manufacturer

Cardiac Science