Events

Safety Alert for heartstart xl defibrillator/ monitor battery m3516a

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
    2012-10-03
  • Event Date Posted
    2012-10-03
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121003a.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 battery m3516a the medicines and healthcare products regulatory agency (mhra), united kingdom and the health canada posted a medical device safety alert concerning heartstart xl defibrillator/monitor battery m3516a, manufactured by philips healthcare. the affected products were labeled with “made in taiwan” and has “r-2011-12” as date of manufacture code. according to philips, the affected battery may not trigger a low battery alarm on the heartstart xl defibrillator/monitor (m4735a). in this case, if the heartstart xl is used on a patient when ac power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning message or audible tone. there is a potential for patient harm if the xl shuts down or becomes inoperable when in clinical use for providing therapy. therefore, philips recommends the following actions: operate the xl with ac power instead of battery power alone. if it is needed to operate the xl on battery power alone, ensure the battery is from a different date of manufacture (it must not have the r-2011-12 date of manufacture code). if unable to operate with ac power alone or locate a battery with a different date of manufacture than that identified above, use an alternative source for treatment or therapy (i.E., backup defibrillator/monitor). according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the mhra and health canada websites as below: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con185586 http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2012-eng.Php if you are in possession of the products, please contact your supplier for information and necessary actions. posted on 3 october 2012.

Device

heartstart xl defibrillator/ monitor battery m3516a
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart XL Defibrillator/ Monitor Battery M3516A
  • Manufacturer
    Philips Healthcare

Manufacturer

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