BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3101918 · Received May 3, 2013

    Report

    Report Number
    1720753-2013-05662
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK WAS REPLACED AND THE FILAMENT WAS CALIBRATED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS UNABLE TO PERFORM X-RAY EXPOSURES DUE TO THE BED BATTERY. THIS MAY CAUSE THE SYSTEM TO BECOME UNUSABLE DUE TO THE INABILITY TO PRODUCE A LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195504 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1