BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1241680 · Received November 19, 2008

    Report

    Report Number
    9680959-2008-00220
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 21, 2008
    Report Date
    November 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    QA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM IS DOWN. THERE IS NO FLUOROSCOPY. THE EXTENDER BOARD WAS ALSO SENT TO THE GE REP TO CHECK THE SIGNAL FLOW FOR THE FLUORO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1