BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTRAK 2500

    MDR report key: 3963723 · Received May 7, 2014

    Report

    Report Number
    1720753-2014-03988
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM SOFTWARE WAS SHUT DOWN AND REBOOTED FOLLING THE INSTRUCTIONS OF THE FSE. THE SYSTEM RETURNED TO A FUNCTIONAL STATE AND BOOTED PROPERLY AS INTENDED. THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO BOOT TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274312 ENTRAK 2500 RADIOLOGICAL IMAGE PROCESSING JAA GE OEC MEDICAL SYSTEMS (SLC) ENTRAK 2500

    Patients

    Seq Age Sex Outcome Treatment
    1