Events

Safety Alert for heartstart xl defibrillator/monitor with m3516a batteries

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-16
  • Event Date Posted
    2013-08-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130816b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: philips heartstart xl defibrillator/monitor with m3516a batteries the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning heartstart xl defibrillator/monitor with m3516a batteries of lot number with ‘lk’ prefix manufactured by philips healthcare. theaccording to the mhra, defibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from six months to three months. this applies to new batteries with the lot number prefix ‘lk’. the mhra clarifies that 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. philips is supplying an addendum (see appendix of the alert) with battery orders and heartstart xl monitor/defibrillator orders stating the changes to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6). the mhra provides the following advice to the affected users: ensure all relevant staff are aware of the changes. ensure that the addendum 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. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con305480 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

heartstart xl defibrillator/monitor with m3516a batteries
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart XL defibrillator/monitor with M3516A batteries
  • Manufacturer
    Philips Healthcare

Manufacturer

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