BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3111911 · Received May 7, 2013

    Report

    Report Number
    1720753-2013-05754
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HANDLE WAS REPLACED 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, "THE HOOK THAT HOLDS ALL THE WIRES AND CORDS HAS COME OFF." THE FSE REPORTED THAT THE LEFT WORKSTATION HANDLE WAS BROKEN. THERE IS NO REPORT OF PATIENT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200081 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1