BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2600

    MDR report key: 1083891 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24056
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED THE GENERATOR FLOPPY DRIVE AND RELOADED THE CUSTOMER'S SOFTWARE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE GENERATOR WOULD NOT BOOT. THE CUSTOMER USED SYSTEM AS IS WITHOUT THE XRAY AND COMPLETED THE CASE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1