Events

Field Safety Notices about HeartStart MRx

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

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(16)
  • Date
    2012-09-10
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/heartstart-mrx&id=597df825-9782-6eee-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
    There is a risk that defibrillators will not respond as intended.
  • Action
    1. Ensure that all device users are aware of the information provided in the attached Field Safety Notice (FSN)issued recently by Philips.  2. Users are instructed to carry out periodic inspections checking for signs of wear. 3. HeartStart MRx users who have detected accelerated cable wear are encouraged to remove the device from use and contact Philips without delay to arrange for a service.  4. Therapy cables / external paddles need replacement every three years.  5. Where possible, users should carry spare cables / paddles.

Device

HeartStart MRx
  • Model / Serial
  • Product Description
    HeartStart MRx
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HPRA