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 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
    2012-08-08
  • Event Date Posted
    2012-08-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120808.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 health canada posted a medical device safety alert concerning heartstart mrx monitor/defibrillator (model no.: m3535a, m3536a), manufactured by philips medical systems. according to the report, the manufacturer has become aware that affected devices may exhibit the following behaviors: in aed mode the device experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to analyze the waveform. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy in addition the devive may provide erroneous alarms (e.G. pvc/min high, vtach, asystole) or indicate an asystolic rhythm when paddles are not in patient contact. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback. for details, please refer to the health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

HeartStart MRx monitor/defibrillator
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

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