BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3950885 · Received June 13, 2014

    Report

    Report Number
    1720753-2014-05079
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 13, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE DRIVE GEAR SHAFT ON THE WHEEL DRIVE CHAIN, THE SHAFT, THE GEARS, AND THE BEARINGS IN THE WHEEL DRIVE MECHANISM WERE GREASED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE STEERING HANDLE WAS DIFFICULT TO TURN. THE SYSTEM WILL REMAIN OPERATION. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351259 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1