BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1141067 · Received September 3, 2008

    Report

    Report Number
    1720753-2008-24413
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM HAS A DEFECTIVE TUBE AND HV CABLE HAS BEEN DAMAGE. THE GE SERVICE REP REPLACED THE HIGH VOLTAGE CABLE AND TUBE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TUBE HAD BEEN ARCING. THE PROBLEM OCCURRED WITH PATIENT ON THE TABLE AND UNDER ANESTHESIA. THE SYSTEM WORKED AFTER A REBOOT. THERE WAS NO INJURY TO THE PATIENT.

    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