Events

Safety Alert Or Field Safety Notices for HeartStart XL defibrillator/monitor with M3516A batteries

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/2013/066
  • Event Number
    CON305480
  • Date
    2013-08-15
  • Event Date Posted
    2013-08-15
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON305480?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
    Seriousdefibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from 6 months to 3 months. this applies to new batteries with the lot number prefix ‘lk’. philips is supplying an addendum with battery orders and heartstart xl monitor/defibrillator orders stating these changes (march 2013) to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6).
  • Action
    Ensure all relevant staff are aware of the changes. Ensure that the addendum (see appendix) is attached to the instructions for use and service manuals accordingly. Be aware that this addendum supersedes any previous guidance given by Philips regarding battery life and capacity test frequency.

Device

HeartStart XL defibrillator/monitor with M3516A batteries
  • Model / Serial
  • Product Description
    HeartStart XL defibrillator/monitor with M3516A batteries of lot number with ‘LK’ prefix. Distributed by Philips and Cardiac Services UK & Ireland. NB: Philips HeartStart XL batteries with lot code prefixes ‘P’, ‘R’, and ‘PCS’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use).  These batteries are still supported with relevant instructions for use and labelling.
  • Manufacturer
    Philips

Manufacturer

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