BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 3823507 · Received February 19, 2014

    Report

    Report Number
    9680959-2014-00251
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 19, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE MONITOR CART FUSE WAS EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY A FLUOROSCOPIC IMAGE. THIS RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105183 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1