Events

Safety Alert Or Field Safety Notices for All HeartStart MRx defibrillators

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Philips Healthcare.

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
    Safety alert / Field Safety Notice
  • Date
    2017-05-24
  • Event Date Posted
    2017-05-24
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-heartstart-mrx-defibrillators-possible-failure-to-deliver-a-shock-cardioversion-pacing-or-monitoring
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Extra notes in the data
    The two problems affecting the HeartStart MRx, may result in a failure to treat cardiac arrest.When the manufacturer has a solution to the problems they will issue another FSN.
  • Reason
    Manufactured by philips healthcare – two battery related problems: 1) may fail to power on or reboots repetitively, 2) after unplugging from ac mains, may fail to deliver a shock or undertake pacing.
  • Action
    Identify affected devices. Ensure alternative devices are available as defined in local risk assessment procedures. Follow the instructions in the Field Safety Notice (FSN) for both problems. Contact Phillips Healthcare to confirm receipt of their FSN.

Device

All HeartStart MRx defibrillators

Manufacturer

Philips Healthcare
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA