BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 3823395 · Received March 26, 2014

    Report

    Report Number
    1720753-2014-02697
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 26, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE 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

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT PRODUCE X-RAY EXPOSURES. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176287 9600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9600

    Patients

    Seq Age Sex Outcome Treatment
    1