BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2500

    MDR report key: 1076084 · Received July 16, 2008

    Report

    Report Number
    1720753-2008-23141
    Event Type
    Malfunction
    Date Received
    July 16, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 1, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP DISCOVERED THAT THE GENERATOR POWER ON CIRCUIT BREAKER CB3 ON THE TOWER WAS BAD. HE REPLACED THE CIRCUIT BREAKER CB3. THE SYSTEM WAS RESTORED TO NORMAL OPERATION AND IS OPERATING AS INTENDED AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2500 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1