BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLAR 9500

    MDR report key: 395719 · Received May 21, 2002

    Report

    Report Number
    MW1025081
    Event Type
    Malfunction
    Date Received
    May 21, 2002
    Date of Event
    January 7, 2002
    Report Date
    May 10, 2002
    Manufacturer
    G.E. MARQUETTE MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE MONITOR HAD A MESSAGE "OVERHEATING" THEN SHUTDOWN. HAD TO BE EXCHANGED IN THE MIDDLE OF SURGERY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/25/03: THE MODEL NUMBER IS SOLAR 9500. THE BRAND NAME IS SOLAR 9500 INFO MONITOR. THE TYPE OF DEVICE IS A PHYSIOLOGICAL PT MONITOR. THE USER FACILITY DID NOT PROVIDE THE SERIAL NUMBER OF THE DEVICE. THE USER FACILITY REPORTED THAT THE SOLAR 9500 PERIODICALLY HAD WARNING MESSAGES REGARDING OVERHEATING AND ONE INCIDENT OF A SHUTDOWN IN THE CARDIOVASCULAR ROOM. THE USER FACILITY INCREASES THE TEMPERATURE IN THE CARDIOVASCULAR OPERATING ROOM TO 90 DEGREES F AT THE END OF THE SURGERY. THE CLINICAL ENGINEER AT THE USER FACILITY CONCLUDED THAT USER ERROR CONTRIBUTED TO THE EVENT. THE FACILITY DETERMINED THEY NEEDED TO CLEAN THE FANS AND REMOVE RESTRICTIONS TO THE AIRFLOW THAT PREVENTED SUFFICIENT VENTILATION OF THE DEVICE. THE CLINICAL ENGINEER AT THE USER FACILITY ENSURED SUFFICIENT VENTILATION OF THE DEVICE AND THEN INCREASED THE AMBIENT TEMPERATURE OF 102 DEGREES F, BEYOND THE OPERATING SPECIFICATIONS AND THEY RECEIVED NO FURTHER ERROR MESSAGES. THE SOLAR 9500 INFO MONITOR OPERATION'S MANUAL INCLUDES SAFETY CAUTIONS ON THE VENTILATION REQUIREMENTS AND ALSO SPECIFIES THE OPERATING TEMPERATURE FOR THE DEVICE 10 DEGREES C TO 35 DEGREES C (50 DEGREES F TO 95 DEGREES F). MFR RECEIVED THE INFO FROM THE USER FACILITY ON MAY 16, 2002. THE DEVICE REMAINS IN USE AT THE USER FACILITY. THE DEVICE IS A SOLAR 9500 INFO MONITORING SYSTEM AND IS INTENDED TO MONITOR PHYSIOLOGIC PARAMETER DATA ON ADULT, PEDIATRIC AND NEONATAL PT IN CRITICAL CARE AREAS SUCH AS OPERATING ROOM, POST ANESTHESIA RECOVERY, CRITICAL CARE, SURGICAL INTENSIVE CARE, RESPIRATORY INTENSIVE CARE, CORONARY CARE, MEDICAL INTENSIVE CARE, PEDIATRIC CARE, OR NEONATAL INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLAR 9500 PHYSIOLOGIC MONITOR MHX G.E. MARQUETTE MEDICAL SYSTEMS SOLAR 9500 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *