BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1149907 · Received September 9, 2008

    Report

    Report Number
    1720753-2008-24555
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 12, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE REP DISCUSSED SYMPTOMS AND ORDERED SUSPECTED REPAIR PART. HE REPRODUCED, VERIFIED AND ISOLATED VERY INTERMITTENT PROBLEM. HE REMOVED THE BAD HIGH VOLTAGE CABLE ASSEMBLY AND INSTALLED NEW CABLE ASSEMBLY, THEN TIGHTENED THE LOOSE INTERCONNECT JACK J1. JCJ J1 IS GOOD. HE TIGHTENED THE LOOSE STEERING HANDLE BRACKET. STEERING BRACKET IS SECURE. REPAIRED CUT CABLE JACKET ON WORKSTATION POWER CORD. POWER CORD IS NOW GOOD. HE CLEANED, LUBRICATED AND TIGHTENED NOISEY STEERING ROD UNIVERSAL JOINT. STEERING "U" JOINT IS NOW GOOD. SYSTEM NOW HAS STABLE IMAGE IN ALL MODES AND POSITIONS. UNIT CHECKS GOOD. ALL FAILED PARTS ARE BEING RETAINED BY THE OWNER FOR STAFF TRAINING AND CANNOT BE RETURNED FOR FAILURE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IMAGE GOES BLACK AND THE KV GOES UP TO THE MAX WHEN THE C-ARM IS PLACED IN A LATERAL POSITION.

    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