Events

Safety Alert for HeartStart XL+ (861290) Defibrillator/Monitor

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
    2012-03-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120323.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: philips heartstart xl+ (861290) defibrillator/monitor medical device manufacturer, philips healthcare, has issued a customer information letter concerning heartstart xl+ (861290) defibrillator/monitor. internal testing showed that when using the device in aed in the following sequence: an alarm condition (e.G. v-fib, v-tach, asystole) occurs the therapy dial is changed from aed mode to any other clinical mode or alarms are enabled in aed mode then any subsequent ecg alarms may not be visible or audible. philips has released a new version of software (a.01.00) that changes the alarm behavior. to mitigate the issue, philips recommends that clinical judgment should be used and the patient’s conditions should be observed when selecting a different clinical mode after aed mode. as an alternative to clear the behavior, exit aed mode and select off, wait ten seconds before entering a different clinical mode. according to the local supplier, the affected devices were distributed to hong kong. the customer information letter will be sent to all affected customers. if you are in possession of the products, please contact your supplier for necessary actions.

Device

HeartStart XL+ (861290) Defibrillator/Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart XL+ (861290) Defibrillator/Monitor
  • Manufacturer
    Philips Healthcare

Manufacturer

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