BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1083686 · Received July 28, 2008

    Report

    Report Number
    1720753-2008-24116
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 29, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND EVIDENCE OF ARCING AT THE CATHODE AND ANODE CONNECTORS AT THE TANK. HE REMOVED CLEANED, AND RE-GREASED THE STICKS AND TIGHTENED AT TUBE AND TANK ENDS. HE VERIFIED PROPER SYSTEM OPERATION. THE SYSTEM OPERATES AS DESIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS ARCING. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1