BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2800

    MDR report key: 1071145 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22942
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 26, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP REPLACED POWER SWITCH. HE RAN AN OPERATIONAL CHECK. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BROKEN POWER ON SWITCH. IT WON'T STAY ON. AS A RESULT, THE SYSTEM WON'T BOOT UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1