BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7686263 · Received July 13, 2018

    Report

    Report Number
    8010042-2018-00359
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 17, 2018
    Report Date
    September 11, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON-SITE BY OUR FIELD SERVICE ENGINEER. IT WAS NOT POSSIBLE TO DUPLICATE THE REPORTED FAILURE. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS CLEARED FOR CLINICAL USE. EVALUATION OF THE RECEIVED DEVICE LOGS SHOW SEVERAL ALARMS FOR HIGH O2 CONCENTRATION IN COMBINATION WITH AIRWAY PRESSURE HIGH AND EXPIRATORY MINUTE VOLUME LOW. AIRWAY PRESSURE HIGH AND EXPIRATORY MINUTE VOLUME LOW ALARMS INDICATE THAT VENTILATION WAS ONGOING BUT WITH HIGHER AIRWAY PRESSURE THAN INTENDED. THE AIRWAY PRESSURE HIGH ALARM IS GENERATED WHEN THE USER SET UPPER PRESSURE LIMIT IS REACHED WHEREBY THE INSPIRATION PHASE IS TERMINATED AND GOES OVER TO EXPIRATION. THE EXPIRATORY MINUTE VOLUME LOW ALARM IS GENERATED WHEN THE MEASURED EXPIRATORY MINUTE VOLUME IS LOWER THAN THE BY THE USER SET LOWER EXPIRATORY MINUTE VOLUME ALARM LIMIT. THE HIGH AIRWAY PRESSURE ALARM AND THE TERMINATION OF THE INSPIRATION PHASE, LEADS TO THAT THE PATIENT NOT RECEIVING THE SET VOLUME AND THIS MAY EITHER BE RELATED TO USER SETTINGS NOT BEING OPTIMAL FOR THE ACTUAL PATIENT, OR AN INCREASED EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM. THERE ARE NO TECHNICAL ERROR CODES THAT INDICATE ANY TECHNICAL ISSUES WITH THE VENTILATOR. THE PRECEDING AND FOLLOWING PRE-USE CHECKS WERE PASSED WITHOUT REMARKS. THERE IS NO RELATIONSHIP BETWEEN THE HIGH O2 CONCENTRATION ALARMS AND THE INDICATION OF EXPIRATORY RESISTANCE IN THE PATIENT¿S BREATHING SYSTEM. THE ROOT CAUSE OF THE HIGH O2 CONCENTRATION ALARMS HAS NOT BEEN DETERMINED. THERE IS NO INDICATION OF VENTILATOR MALFUNCTION AT THE TIME OF EVENT. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF: EXEMPTION#: E2018003. GETINGE USA SALES, LLC. (B)(4).

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERON: (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT WAS GIVING MULTIPLE HIGH O2 CONCENTRATION ALARMS. THE VENTILATORS LOGS ALSO CONTAINED EXPIRATORY MINUTE VOLUME LOW AND AIRWAY PRESSURE HIGH ALARMS. THERE WAS NO PATIENT HARM. MANUFACTURER REFERENCE#: (B)(4). IMPORTER REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528239 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1