BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO-I

    MDR report key: 940964 · Received November 8, 2007

    Report

    Report Number
    8010042-2007-00254
    Event Type
    Death
    Date Received
    November 8, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 12, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K063404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE LOGS CONFIRM THE GENERATION OF THE REPORTED ALARMS. THE TECHNICAL LOGS HAVE NO ENTRY ON THE DAY OF EVENT INDICATING THAT THERE WAS NO VENTILATOR MALFUNCTION LOGGED ON THE DAY OF THE EVENT. THE ALARM "PAW HIGH" IS LOGGED MANY TIMES. THIS INDICATES GAS BEING DELIVERED AND A FUNCTIONING VENTILATION SYSTEM. ALSO LOGGED IS A "PEEP HIGH" ALARM (POSITIVE END EXPIRATORY PRESSURE HIGHER THAN USER SET UPPER LIMIT). THIS INDICATES AN INCREASED RESISTANCE TO EXHALE. IN THE PRESSURE CONTROL MODE THE PRESET PRESSURE LEVEL IS CONTROLLED BY THE VENTILATOR. THE RESULTING VOLUME DEPENDS ON THE PRESET PRESSURE LEVEL, INSPIRATION TIME AND THE PT'S LUNG MECHANICAL PROPERTIES DURING EACH BREATH. IF THERE IS AN INCREASED RESISTANCE IN THE PT OR IN THE PT CIRCUIT THE PRESET PRESSURE LEVEL WILL BE ATTAINED BUT THE RESULTING DELIVERED VOLUMES WILL DECREASE, THE USER SET/DEFAULT EXPIRATORY MINUTE VOLUME LOWER ALARM LIMIT MAY BE EXCEEDED AND THE ALARM GENERATED. THERE IS NO INDICATION OF LEAKAGE THUS THE DESCRIBED DECREASING DELIVERED VOLUMES IS MOST LIKELY A SYMPTOM OF INCREASING RESISTANCE THAT THE USER MUST HANDLE ADEQUATELY. OUR CONCLUSION IS THAT THERE WAS NO VENTILATOR MALFUNCTION. THE VENTILATOR DELIVERED GAS FLOW DURING THE ENTIRE PERIOD, FUNCTIONED AND ALARMED AS IT SHOULD. THE HOSPITAL BIOMED FOUND IT FUNCTIONING NORMALLY AFTER THE EVENT. IT PASSED THE PRE-USE CHECKS, NO PARTS WERE REPLACED AND IT WAS PUT BACK IN SERVICE. MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PT WAS BEING VENTILATED IN THE PRESSURE CONTROL VENTILATION MODE. THE PT COUGHED SOMETIMES AND ALARMS "PAW HIGH" (HIGH AIRWAY PRESSURE EXCEEDING THE USER SET UPPER PRESSURE LIMIT) AND "EXPIRATORY MINUTE VOLUME LOW" (MINUTE VOLUME LOWER THAN THE USER SET LOWER LIMIT) WERE GENERATED. THE INSPIRATION SEEMED TO BE TOO LOW. ACCORDING TO THE NURSES THE VENTILATOR SEEMED TO DELIVER LESS AND LESS GAS. THE PT'S THORAX DIDN'T MOVE. THE PT WAS DISCONNECTED AND VENTILATED MANUALLY AND THE PT'S THORAX MOVED. THE PT WAS RECONNECTED TO THE VENTILATOR AND IT WAS NOTICED THAT SPO2 (PERIPHERAL OXYGEN SATURATION) WAS DECREASING. THERE WAS CARDIAC ARREST AND THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death