BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4251213 · Received November 5, 2014

    Report

    Report Number
    1720753-2014-09154
    Event Type
    Malfunction
    Date Received
    November 5, 2014
    Date of Event
    September 29, 2014
    Report Date
    November 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE VIDEO CONTROLLER CABLE CONNECTORS WERE RESEATED 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 SYSTEM WOULD NOT BOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710254 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1