Events

Safety Alert for Automated External Defibrillator HeartStart Home and Onsite (HS1)

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
    2014-03-07
  • Event Date Posted
    2014-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140307.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 healthcare automated external defibrillator heartstart home and onsite (hs1) medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning automated external defibrillator (aed) heartstart home and onsite (hs1) with model numbers m5066a and m5068a. the affected products were manufactured in july 2013. according to the manufacturer, in a limited number of heartstart home and onsite (hs1) aeds, one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed. if poor contact between the pads cartridge and aed occurs, the device may be unable to deliver therapy in an emergency. the manufacturer will replace the affected aeds for their customers. meanwhile, users are advised to keep the aeds in service if there are no alternative defibrillators readily available. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

Automated External Defibrillator HeartStart Home and Onsite (HS1)
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart Home and Onsite (HS1)
  • Manufacturer
    Philips Healthcare

Manufacturer

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