Events

Safety Alert for Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)

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
    2012-03-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120306a.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
    Field safety notice: carry case used with the heartstart fr3 automated external defibrillator (aed) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the carry case used with heartstart fr3 aed, manufactured by philips healthcare. according to the manufacturer, the heartstart fr3 aed itself is not part of this action. only the small soft carry cases [model numbers 989803173711 (philips) and 989803173721 (laerdal)] manufactured by philips and shipped between may 2011 and august 2011 are part of this action. all small soft cases, models 989803173711and 989803173721, are affected. the model number can be found on the carry case label, located directly under the fr3 when it is stored in the case. the affected small soft carry cases incorporate a magnet in the lid that automatically turns the fr3 aed on when the case is opened. if the case is not aligned properly when closed, the fr3 may interpret the resulting intermittent misalignment of the magnet as a case opening. thus, the aed may turn on repeatedly while stored in the case, inadvertently depleting the battery. the manufacturer warned users that a drained battery may not allow the fr3 to deliver therapy in case of an emergency. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Manufacturer
    Philips Healthcare

Manufacturer

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