Events

Safety Alert for Heartstart MRx Defibrillator/Monitor

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
    2014-12-31
  • Event Date Posted
    2014-12-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141231.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 defibrillator/monitor medical device manufacturer, philips medical systems, has issued a medical device safety alert concerning its heartstart mrx defibrillator/monitor. the affected products are as follows:- model m3535a: serial number us00100100 to us00578696 model m3536a: serial number us00100902 to us00576650 model m3536j: serial number us00209838 to us00332675 model m3536m: serial number us00500002 to us00553553 model m3536mc: serial number us00500001 to us00500087 model m3536m2: serial number us00554176, us00554177, us00554178 model m3536m4: serial number us00500003 to us00574869 model m3536m5: serial number us00500001 to us00562935 model m3536m6: serial number us00554358 to us00576619 the manufacturer has identified that under certain circumstances, the mrx monitor/defibrillator could reboot once in any operating mode if the following sequence occurs: in service mode, the status log is cleared prior to exiting service mode, the mrx generates an entry in the status log. mservice mode is exited. the mrx is then in a state that could trigger a reboot at an indeterminate time. a reboot during the application of therapy or pacing could potentially cause interrupted pacing or a delay of defibrillation or cardioversion therapy. the mrx will restart within 8 seconds. the manufacturer advises that affected users can continue to use the devices prior to receiving the software upgrade. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 december 2014.

Device

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

Manufacturer

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