BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1083867 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24108
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 29, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP VERIFIED THE PIN WAS BROKEN IN THE INTERCONNECT AT THE C-ARM END. HE REMOVED THE C-ARM COVERS AND EXTRACTED PINS FROM THE P-1 THEN RECORDED POSITIONS OF WIRES TO P-3. HE REPAIRED THE P-1 TO P-3 AND TESTED THE SYSTEM. THE C-ARM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CONTROL PANEL WAS BROKEN. THE PIN ON THE RECEPTACLE WAS BENT, WHEN TECH ATTEMPTED TO STRAIGHTEN THE PIN, IT BROKE. NO PT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1