BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1141206 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24434
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 7, 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 ADJUSTED THE WIG WAG BRAKE TO MANUFACTURER'S SPECS. HE TROUBLESHOOT SHUTTERS PROBLEM AND FOUND THEY WERE INTERMITTENTLY FAULTY. HE INSPECTED HIGH VOLTAGE CABLE AND FOUNDED OPEN ON WIRES 1 AND 2 OF P10 ON THE COLLIMATOR. PART IS ON ORDER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE COLLIMATOR SHUTTERS ARE NOT WORKING AND THE WIG WAG BROKE WAS LOOSE.

    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