BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2971754 · Received February 6, 2013

    Report

    Report Number
    9680959-2013-00309
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 26, 2013
    Report Date
    February 6, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS, CABLES, AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT MAKE AN EXPOSURE. THIS RESULTED IN NO LIVE IMAGE BEING DISPLAYED. THIS COULD RESULT IN THE DELAY OR CANCELLATION OF A PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51208 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1