Events

Safety Alert Or Field Safety Notices for Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.

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
    2018-11-29
  • Event Date Posted
    2018-11-29
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/batteries-for-the-heartstart-mrx-monitor-defibrillator-may-fail-to-charge-or-to-provide-power
  • 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
    This MDA is related to our previous alert, MDA/2018/002, advising users of a significant delay in the supply of batteries for the HeartStart MRx monitor/defibrillator.The supply of batteries for these devices has been halted again due to further manufacturing problems. There is likely to be an ongoing significant delay in the fulfilment of outstanding orders.
  • Reason
    Philips m3538a lithium-ion batteries manufactured from 28 december 2017 to 20 march 2018 inclusive for the heartstart mrx monitor/defibrillator may have an internal component failure.
  • Action
    Identify affected batteries highlighted in the manufacturer’s Field Safety Notice and remove them from service. Ensure alternative devices are available as defined in local risk assessment procedures until you can source a new battery. Follow the manufacturer’s instructions for use on battery management to keep your existing batteries in the best possible condition. Ensure there are systems in place to replace affected batteries as a priority when supplies are resumed.

Device

Batteries for the HeartStart MRx monitor/defibrillator may fail to charge or to provide power.
  • Model / Serial
  • Manufacturer
    Philips

Manufacturer

Philips
  • Manufacturer Address
    Clare Fripp Head of Q&R Philips UK& Tel: 07920 763 640Email: clare.fripp@philips.com
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    MHRA