BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1071114 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22893
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND A BAD PIN CONNECTION AT XRAY TUBE CATHODE CONNECTOR. HE VERIFIED MA VALUES WERE 30% LOW AT HVPS SENSE LINE. MA VALUES RETURNED TO NORMAL AFTER RESEATING TUBE CATHODE CONNECTOR. PROBLEM WOULD NOT RETURN. MA CIRCUIT IS FUNCTIONING PROPERLY. THE REP ORDERED A NEW CLIMAX COUPLING FOR INHOUSE REPLACEMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD A LOW MA WARNING MESSAGE THAT APPEARED ON THE CARM DISPLAY DURING CASES. NONE OF THE PROCEDURES WERE ADVERSELY AFFECTED. NO INJURIES.

    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