BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC, 9900

    MDR report key: 809964 · Received December 26, 2006

    Report

    Report Number
    809964
    Event Type
    Malfunction
    Date Received
    December 26, 2006
    Date of Event
    September 13, 2006
    Report Date
    November 2, 2006
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    FOLLOWING STANDARD OPERATING PROCEDURE THE DOCTOR CALLED FOR C-ARM TO VERIFY CATHETER PLACED DURING PROCEDURE. THE C-ARM, AN OEC 9900, FAILED ON START UP GIVING A "HV REGISTER FAIL". A SECOND C-ARM ALSO AN OEC 9900 WAS BROUGHT IN. THE CASE PROCEEDED FOR JUST A COUPLE OF MINUTES BEFORE THIS C-ARM ALSO FAILED WITH THE DISPLAY MINIMIZING TO A VERY SMALL CIRCLE, TOO SMALL FOR THE DOCTOR TO PROCEED. A THIRD C-ARM WAS LOCATED AND THE CASE WAS FINISHED. DUE TO THE MULTIPLE C-ARM FAILURES THERE WAS APPROXIMATELY A 20 MINUTE TIME PERIOD FROM DURING WHICH THE PATIENT HAD A CATHETER IN PLACE WITHOUT CONFIRMATION OF PROPER POSITION. SERVICE CALLS WERE PLACED WITH GE, AS BOTH UNITS ARE STILL UNDER WARRANTY. PRINTED CIRCUIT BOARDS (PCBS) WERE REPLACED IN BOTH UNITS TO ADDRESS THE PROBLEMS AND THE UNITS WERE RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC, 9900 X-RAY SYSTEM, C-ARM JAA GE MEDICAL SYSTEMS, LLC 9900 *
    2 OEC, 9900 X-RAY SYSTEM, C-ARM JAA GE MEDICAL SYSTEMS, LLC 9900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR