Events

Safety Alert for HeartStart MRx Monitor/Defibrillator

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Philips Medical Systems.

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_20140226.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/defibrillator medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning heartstart mrx monitor/defibrillator. the affected model numbers are m3535a, m3536a, m3536j, m3536m, m3536m5, and m3536mc, and the affected serial numbers are within the range us00100100 - us00550668. the ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause loss of demand mode pacing, inability to perform synchronized cardioversion with paddles, and disruption of leads ecg monitoring, which could delay appropriate treatment. defibrillation, fixed mode pacing, ecg monitoring via pads/paddles, and other monitoring functions are not impacted by this issue. the manufacturer will provide a hardware upgrade on all affected units. users can continue to use mrx prior to receiving the hardware upgrade. if the above problem occurs, users should refer to the heartstart mrx instructions for use for troubleshooting assistance and follow the technical advice as listed in the fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

HeartStart MRx Monitor/Defibrillator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH