Events

Safety Alert for HeartStart MRx Monitor/Defibrillator with Q-CPR

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

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
    2015-09-01
  • Event Date Posted
    2015-09-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150901a.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 with q-cpr medical device manufacturer, philips, has issued a medical device safety alert concerning its heartstart mrx monitor/defibrillator with q-cpr. the affected devices are identified as follows:-  units affected: all q-cpr meter and cpr sensor;  model number: 453564145481, 453564257691 and m4761a during internal review, the manufacturer identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. in addition, instructions did not inform the users that properly performed cpr can result in injuries to the patient. the manufacturer has updated the heartstart mrx’s instructions for use associated with q-cpr sensor via an addendum. the addendum has instructions on application of the disposable adhesive pads, which are used with the q-cpr meter, including a diagram which illustrates proper placement and orientation of this pad. in addition, the addendum includes general information on the types of injuries, which may occur during cpr. according to the local supplier, the q-cpr meter and cpr sensor are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 september 2015.

Device

HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillator with Q-CPR
  • Manufacturer
    Philips

Manufacturer

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