BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 2960588 · Received January 25, 2013

    Report

    Report Number
    9680959-2013-00240
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 25, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP CONTACTED THE CUSTOMER BY PHONE AND DIRECTED THEM IN REPAIRING THE SYSTEM. NO FURTHER REPAIR INFO IS AVAILABLE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT START UP. 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
    35393 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

    Patients

    Seq Age Sex Outcome Treatment
    1