Events

Safety Alert for heartstart mrx monitor/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
    2014-02-26
  • Event Date Posted
    2014-02-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140226a.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 mrx monitor/defibrillators medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator. the affected model numbers and serial numbers are as follows: m3535a: us00100104 - us00572207 m3536a: us00100902 - us00543688 m3536j: us00209838 - us0332675 m3536m: us00500002 - us00500009 m3536mc: us00500002 - us00500028 when used in hospital transport and pre-hospital environments, the connection between the pads/paddles therapy cable (including pads cpr therapy cable, external paddles cable, and internal paddles cable/adapter) and the mrx therapy connection port could experience high levels of stress causing accelerated wear. wear of the connection could prevent the device from sensing that the pads/paddles therapy cable is connected. this wear could also cause the affected product to inappropriately identify the pads therapy cable, external paddles, or internal paddles. pads/paddles therapy cable and therapy connection port wear could pose a risk for patients and/or caregivers. the manufacturer will arrange inspection of the affected units and install a stabilizing collar if necessary. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

heartstart mrx monitor/defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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