BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3013144 · Received March 1, 2013

    Report

    Report Number
    1720753-2013-03235
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 1, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM BATTERY PACK WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR MESSAGE AND SHUT DOWN. THE SYSTEM THEN COULD NOT BE REBOOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90338 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900

    Patients

    Seq Age Sex Outcome Treatment
    1