BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 1191344 · Received October 9, 2008

    Report

    Report Number
    1720753-2008-22701
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP COULD NOT REPLICATE THE PROBLEM. HE REMOVED ALL BOARDS FROM THE BACK OF THE WORKSTATION AND CHECKED ALL THE FUSES ON THE BACKPLANE WERE SEATED PROPERLY. REINSTALLED ALL BOARDS AND BOOTED SYSTEM UP. FOUND NO SEATING ISSUES WITH THE FUSES OR BOARDS. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM DID NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1