Events

Safety Alert Or Field Safety Notices for All Philips HeartStart MRx monitors/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.

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
    2018-01-15
  • Event Date Posted
    2018-01-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/all-philips-heartstart-mrx-monitors-defibrillators-significant-delay-in-the-supply-of-batteries
  • 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
  • Reason
    The supply of batteries for these devices has been temporarily stopped so there may be a significant delay in the fulfillment of orders for new batteries.
  • Action
    Identify affected devices. Ensure alternative devices are available as defined in local risk assessment procedures should you be unable to source a new battery. Follow the manufacturer’s instructions for use on battery management to keep your existing batteries in the best possible condition. Philips have stated that they expect to resume shipments of the MRx battery by 23rd January. Please contact Philips directly for any specific update relating to any orders.

Device

All Philips HeartStart MRx monitors/defibrillators
  • Model / Serial
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Address
    Philips Medical Systems Tel: 0870 531 9741Email: steve.leonard@philips.com
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA