BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3884260 · Received May 20, 2014

    Report

    Report Number
    1720753-2014-04321
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. A SYSTEM BATTERY WAS EVALUATED AND REPLACED. THE BIOS SETTINGS WERE ALSO EVALUATED AND RESET. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYS FAILED TO BOOT UP 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
    298638 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1