Events

Safety Alert for hs1 and heartstart frx automatic external defibrillators

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
    2012-11-30
  • Event Date Posted
    2012-11-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121130.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 hs1 and heartstart frx automatic external defibrillators medical device manufacturer, philips healthcare, has issued an advisory regarding heartstart hs-1 and heartstart frx automatic external defibrillators. the manufacturer has determined that it is important to clarify information in the owner’s manual and keep the users of heartstart frx and hs1 informed about the maintenance of the frx or hs1 heartstart automated external defibrillators (aeds). the manufacturer advised users that in case of single chirps, if the frx or hs1 aed emits a pattern of single chirps(♪...♪...♪...), press the blue i-button on the front of the device for information. the aed will tell the user exactly what actions to take to ensure that the device is ready for use. in case of triple chirps, if at any time during the life of the device, the frx or hs1 aed emitted or begins to emit a pattern of triple chirps (♪♪♪...♪♪♪...♪♪♪...), it is important that the user remove the device from use, and contact the local philips representative. if an frx or hs1 aed emits a pattern of triple chirps, it is a signal that the device requires investigation by philips to ensure that it is ready for use. of course, if needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the owner’s manual. however, even if the user has been able to clear the error, it is important that the user contact the local philips representative to obtain the tools and information the user need to ensure that the device is functioning properly. users should update their protocols accordingly. in addition, the manufacturer has created a website with additional information about this action. to hear the difference between single chirps and triple chirps emitted by these aeds, visit the manufacturer’s website at www.Philips.Com/heartstartmaintenanceadvisory. according to the local supplier, philips electronics hong kong ltd., the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 november 2012.

Device

hs1 and heartstart frx automatic external defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart HS1 and HeartStart FRx Automatic External Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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