BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1343339 · Received January 30, 2009

    Report

    Report Number
    9680959-2009-00014
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    January 6, 2009
    Report Date
    January 29, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP COULD NOT DUPLICATE THE PROBLEM. HE TESTED THE THERMO SENSOR AND NO PROBLEM WAS FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WILL NOT FLUORO. THE TEMPERATURE HAD FALLEN BELOW THE MINIMUM. THEY HAD TO CEASE PROCEDURE AND WERE UNABLE TO COMPLETE THE PROCEDURE.

    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