BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1083846 · Received July 29, 2008

    Report

    Report Number
    1720753-2008-24111
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPAIRED THE POWER CORD. THE WIRES HAD BEEN PULLED AWAY FROM THE TERMINALS ON THE POWER CORD. HE ALSO REPLACED THE CMOS BATTERY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THERE WAS NO POWER AT THE WORKSTATION BECAUSE THE POWER CORD NEEDED TO BE REPAIRED.

    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