BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC

    MDR report key: 1040783 · Received May 9, 2008

    Report

    Report Number
    1720753-2008-21363
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 29, 2008
    Report Date
    May 7, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REP FOUND AND CORRECTED LOOSE CONNECTION ON TEMP SENSOR. TESTED SYSTEM BY REBOOTING WITH NO ERRORS AND FLUORING FOR 5 MINUTES. SYSTEM OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM MADE A POPPING NOISE, AND DISPLAYED A BAD TEMP SENSOR. THE CUSTOMER TURNED OFF AND THEN SAYS HOT HOUSING PROBLEM BEGAN TODAY, DURING A CASE, NO INJURY, PROCEDURE COMPLETED ON ANOTHER MACHINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1