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
    42948
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-16
  • 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 could reboot once in any operating mode if the following sequence occurs: 1. in service mode the status log* is cleared 2. prior to exiting service mode the device generates an entry in the status log. 3. service mode is exited. the heartstart mrx device is then in a state that could trigger a reboot at an indeterminate time potentially causing therapy to be interrupted or delayed. the heartstart mrx device will restart within 8 seconds. note: if a reboot occurs during clinical use current device settings and patient record are retained. *the status log is a tool accessed by service personnel. it includes entries for all messages logged during normal operating mode automated tests service and configuration mode and operational checks. the heartstart mrx defibrillator/monitor service manual instructs service personnel to clear the status log after successful completion of an operational check.

Device

HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Model / Serial
    Model Catalog: M3536A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3536A:); Model Catalog: M3535A (Lot serial: FOR MODEL M3535A:); Model Catalog: M3536A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100100 to US00578696); Model Catalog: M3535A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: US00100902 to US00576650); Model Catalog: M3536A (Lot serial: FOR MODEL M3535A:)
  • Product Description
    HEARTSTART MRX DEFIBRILLATOR/MONITOR
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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