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
    2013-04-19
  • Event Date Posted
    2013-04-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130419a.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 concerning heartstart mrx monitor/defibrillator [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5, m3536m6; serial numbers within the range us00100100 to us00565942] according to the manufacturer, the philips heartstart mrx monitor/defibrillator may fail to deliver defibrillation therapy in either manual defib or aed mode. if this occurs, the mrx may simultaneously display a “no shock delivered” message along with a “shock equip malfunction”, inop and a red x in the rfu indicator. in addition, the pads ecg waveform may display a non-physiologic flat line rhythm. if the problem occurs, there may be a failure to deliver shock therapy to a patient in need of defibrillation or cardioversion therapy. the manufacturer will provide software upgrade to fix the problem. however, prior to performing the software upgrade, the manufacturer recommends customer to follow step 1. step 1: if the problem occurs, disregard the mrx “no shock delivered”, “shock equip malfunction”, inop and the red x. press the lead select button to display another ecg waveform and continue to administer additional shock therapy as needed. if step 1 does not resolve the problem follow step 2. step 2: treat your patient per existing protocols. if possible, philips recommends that a backup defibrillator be made available. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

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