Events

Field Safety Notices about HeartStart MRx

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Philips.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Philips has determined that there is a possibility of abnormal operation of the heartstart mrx monitor / defibrillator. in extremely rare cases, the following operating patterns may occur on the device: 1. if the pins with which the battery is attached to the device are damaged or dirty, the electrical connection may be poor. when the device is powered only by a battery, the device may not turn on or restart; 2. when the heartstart mrx monitor / defibrillator is disconnected from the power supply and a single battery is used as the sole power source, the following patterns of abnormal device operation may occur: a. when the user presses the charge button, the device attempts to charge, and after about 20 seconds, displays a "shock equipment malfunction" error message and is unable to perform shock treatment; b. the promotion may be interrupted without warning. these device performance patterns may occur until the unit is reset. both of these problems can cause a delay in monitoring or treatment.

Device

HeartStart MRx

Manufacturer

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