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_20140226b.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: model m3535a: us00100100 to us00541372 model m3536a: us00100902 to us00541375 model m3536j: us00209838 to us00332675 model m3536mc: us00500001 to us00500020 according to the manufacturer, a component of the mrx processor board may be susceptible to damage from electrostatic discharge. damage to these components can disrupt electrocardiography (ecg) and pulse oximetry (spo2) functionality leading to an inability to perform: demand mode pacing 12 lead ecg acquisition and analysis ecg monitoring via leads pulse oximetry (spo2) the presence of this condition will be displayed on the ready for use indicator as a solid red x with periodic audio chirp. a hardware upgrade will be provided to correct the issue. the manufacturer advises healthcare professionals that the affected product can continue to be used prior to receiving the hardware update. the manufacturer also provides instruction for the appropriate actions to be taken if the affected product displays a solid red ‘x’. 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