BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 2960609 · Received January 25, 2013

    Report

    Report Number
    9680959-2013-00239
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    November 22, 2012
    Report Date
    January 25, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPAIRED 4 GUIDE PINS IN THE INTERCONNECT CABLE CONNECTOR. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FSE REPORTED THAT THE SYSTEM WOULD NOT BOOT UP BECAUSE THE INTERCONNECT CABLE COULD NOT BE CONNECTED. THIS RESULTED IN A TOTAL LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35472 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1