BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1083659 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24034
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 16, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBE WAS ARCING LOUDLY SO THE MACHINE WAS TAKEN OUT OF SERVICE. IT MADE A LOUD BANG AND THEN SHUT DOWN. A PATIENT WAS INVOLVED BUT NOT INJURED. THEY COMPLETED THE PROCEDURE WITH ANOTHER UNIT.

    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