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
    2013-06-14
  • Event Date Posted
    2013-06-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614.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 medical device safety alert concerning certain models of heartstart mrx monitor/defibrillators [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5 and m3536m6]. the affected units include those manufactured by philips between february 2004 and february 2013, and shipped worldwide with serial numbers within the ranges us00100100 and us00565942. a philips heartstart mrx monitor/defibrillator operating on battery power only that is used in-hospital or in pre-hospital environments may shutdown without warning if exposed to elevated levels of electromagnetic interference from other radio frequency (rf) energy sources and continuous repetitive power line bursts. examples of other equipment that can cause interference are other medical devices, cellular products, information technology equipment and radio/television transmissions. the manufacturer provides the following information and advice the condition can be avoided by operating the device on external ac or external dc power. when using battery power only, users should follow the device instructions to minimize or eliminate potential interference from other rf sources. see mrx ifu section, safety considerations, emissions and immunity for proper use of your mrx relative to electromagnetic emissions. if the device powers down and the battery fuel gauge lights appear off or dim, users should perform the following: remove any potential source of rf interference from the environment replace the battery with a fully-charged battery with five solid, bright green lights on the battery fuel gauge or connect an external power source in addition, the manufacturer will provide an ifu addendum titled "heartstart mrx electromagnetic compatibility" for all customers with affected units. according to the local supplier, 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 14 june 2013.

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