Events

Recall of HEARTSTART MRX DEFIBRILLATOR/MONITOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    91530
  • Event Risk Class
    II
  • Event Initiated Date
    2014-11-21
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Philips has become aware that the heartstart mrx defibrillator/monitor may contain incorrect internal software settings causing the following two (2) issues: 1. the device will perform the weekly automated tests hourly which could cause the therapy capacitors to degrade sooner than intended. 2. while connected to ac or dc power and with no battery installed or the battery installed has a charge level of less than 10% the ready for use (rfu) indicator will not provide the expected low battery indication (flashing red x with audible chirp). instead the rfu will show a flashing black hourglass indicating that sufficient battery power is available for device operation. note: once the device is disconnected from ac or dc power the rfu indicator provides the appropriate low battery indications. in addition all other battery charge indicators continue to operate normally including the onscreen battery fuel gauges low battery messages and low battery alarms. the led charge level indicators on the batteries themselves also operate normally.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Model / Serial
    Model Catalog: M3536A (Lot serial: ALL); Model Catalog: M3535A (Lot serial: ALL)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC