BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-N

    MDR report key: 8032475 · Received November 2, 2018

    Report

    Report Number
    8010042-2018-00585
    Event Type
    Injury
    Date Received
    November 2, 2018
    Date of Event
    October 17, 2018
    Report Date
    February 27, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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).

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. (B)(4). NO PARTS WERE REPLACED THEREFORE THE INVESTIGATION IS AN EVALUATION OF THE VENTILATOR¿S LOGS AND THE AVAILABLE INFORMATION. THE PATIENT WAS VENTILATED FOR 4 DAYS AND BASICALLY IN THE PRVC (PRESSURE REGULATED VOLUME CONTROL) MODE OF VENTILATION. THE PRVC VENTILATION PERIODS ARE CHARACTERIZED BY PRESENCE OF VERY MANY ¿VOLUME DELIVERY RESTRICTED¿ ALARMS. THESE ALARMS INDICATE RESTRICTION OF DELIVERED VOLUMES DUE TO A REACHED PRESSURE LIMIT OF 5 CM H2O BELOW THE SET UPPER PRESSURE LIMIT. WHEN THE ALARM OCCURS THE ONGOING INSPIRATION IS TERMINATED AND VENTILATION GOES OVER TO EXPIRATION. THE DELIVERED VOLUMES WILL BE LESS THAN INTENDED. THE LOGS FURTHER SHOW THAT THE PATIENT¿S AVERAGE ONE MINUTE BREATH BY BREATH DYNAMIC COMPLIANCE CDYN WAS VARYING WITH VALUES AT TIMES SO LOW THAT THE TARGET VOLUME TO THE PATIENT COULD NOT BE MET BECAUSE IT REQUIRED A HIGHER PRESSURE THAN THE UPPER PRESSURE ALARM LIMIT COULD ALLOW. ADDITIONAL INFORMATION FROM THE HOSPITAL STATED THAT THE PATIENT HAD RDS WHICH SUPPORTS THE LOW CDYN VALUES. THE PATIENT WAS ALSO VENTILATED IN THE PC (PRESSURE CONTROL) MODE OF VENTILATION FOR ABOUT 2½ HOURS AND THIS PERIOD WAS VIRTUALLY PROBLEM FREE. THERE WAS NO VENTILATOR MALFUNCTION AT THE TIME. THE VENTILATOR FUNCTIONED AS IT SHOULD WITH THE SET PARAMETERS AND ALARMED FOR THE PREVAILING CONDITIONS. THE REPORTED NON-MOVEMENT OF THE CHEST WAS A RESULT OF TERMINATED BREATHS AND LOW EXPIRED VOLUMES TO WHICH THE VENTILATOR RESPONDED WITH APPROPRIATE ALARMS. THE CAUSE WAS THE INAPPROPRIATE MODE OF VENTILATION AT THE TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT WAS OBSERVED THAT THE PATIENT SHOWED NO CHEST MOVEMENTS AND THE VENTILATOR WAS ALARMING AND GIVING LOW EXPIRATORY MINUTE VOLUME ALARMS. THE PATIENT¿S SAO2 WAS DROPPING AND THE PATIENT GOT BRADYCARDIA. THE VENTILATOR WAS DISCONNECTED FROM THE PATIENT. THE PATIENT WAS VENTILATED WITH AN INFANT T-PIECE RESUSCITATOR. THE DISCONNECTED VENTILATOR WAS BLOWING GASES OUT IN THE OPEN AND ITS RESPIRATORY RATE WENT UP TO 300 BREATHS PER MINUTE. IT WAS CONNECTED TO A TEST LUNG AND THE RESPIRATORY RATE DROPPED BACK TO THE SET 50 BPM. THE VENTILATOR WAS THEN RECONNECTED BACK TO THE PATIENT. AFTER RECONNECTION THE RESPIRATORY RATE ROSE TO 200 BPM AND NO CHEST MOVEMENTS WERE OBSERVED WITH THE PATIENT. THE VENTILATOR WAS REPLACED WITH ANOTHER DEVICE. THE FINAL PATIENT OUTCOME WAS NO INJURY. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE#:(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874189 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening