Events

Safety Alert Or Field Safety Notices for HeartStart XL defibrillator/monitor

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
  • Event ID
    MDA/2012/077
  • Event Number
    CON203886
  • Date
    2012-11-08
  • Event Date Posted
    2012-11-08
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON203886?tabName=allTabs
  • 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
    Risk of immediate and unexpected loss of critical monitoring, defibrillation or non-invasive pacing. if a heartstart xl defibrillator/monitor is not connected to the mains and is used with a battery from the affected batch, it may shut down unexpectedly without providing the user with a low battery warning or audible alarm. the manufacturer published a field safety notice in september 2012 to notify users and prompt them to take action.  the manufacturer has not received sufficient confirmation that this fsn had been received and acted upon.
  • Action
    Identify HeartStart XL defibrillator/monitors with affected batteries and affected spare batteries. If you have affected batteries, follow the guidance given in the Field Safety Notice. In particular: do not use device on battery power alone, and ensure you have access to an appropriate alternative device. Contact the manufacturer to arrange for a replacement battery.

Device

HeartStart XL defibrillator/monitor
  • Model / Serial
  • Product Description
    Batteries for HeartStart XL defibrillator/monitor. Battery part number M3516A. Batch labelled ‘Made in Taiwan’ with ‘Date of Manufacture’ code ‘R-2011-12’.
  • Manufacturer
    Philips

Manufacturer

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