BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3981059 · Received July 24, 2014

    Report

    Report Number
    1720753-2014-06325
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GIB BATTERY, RTOS COIN BATTERY AND GPOS COIN BATTERY WERE ALL EVALUATED AND REPLACED. THE FSE PERFORMED A CLEAN SOFTWARE INSTALLATION AS PART OF THE SERVICE EVENT. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED 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
    434753 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1