BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1980156 · Received January 24, 2011

    Report

    Report Number
    9680959-2011-00090
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 24, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE X-RAY TUBE. SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE TEMPERATURE WARNING LIGHT IS ON AT BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1