BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8322739 · Received February 8, 2019

    Report

    Report Number
    8010042-2019-00078
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 20, 2019
    Report Date
    April 15, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 (B)(4). CONTACT PERON: (B)(4). THE REPORTED EVENT WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE). THE INVOLVED VENTILATOR WAS NOT INVESTIGATED BY OUR FSE DUE TO THAT THE VENTILATOR WAS STILL IN CLINICAL USE. NO PARTS HAVE BEEN REPLACED. OUR FSE FOUND THAT A FILTER WAS USED ON THE INSPIRATORY SIDE. WHEN THE INSPIRATORY FILTER WAS REMOVED, THE ISSUE WITH THE 1-3 CMH2O PRESSURE SPIKES AT THE END OF INSPIRATION DISAPPEARED AND NO FURTHER ISSUES HAVE BEEN REPORTED AFTER THIS. THE FILTER WAS NOT MANUFACTURED OR DISTRIBUTED BY US. THE 1-3 CMH2O PRESSURE SPIKES WERE NOT RELATED TO LEAKAGE AS WAS REPORTED INITIALLY. A SCREEN PICTURE SHOWING THE FLOW AND PRESSURE CURVES WAS RECEIVED. EVALUATION OF THE SCREEN PICTURE CAN CONFIRM THE REPORTED 1-3 CMH2O PRESSURE SPIKES IN THE END OF INSPIRATION. THE DEVICE LOGS WERE NOT RECEIVED. THE VENTILATOR IS STILL IN CLINICAL USE.

    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). MANUFACTURER REF. #:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, THERE WERE SMALL PRESSURE SPIKES AT THE END OF INSPIRATION LEADING TO PEAK PRESSURES RISES OF 1-3 CMH2O WHEN LEAKAGE WAS PRESENT. THE SPIKES DISAPPEARED ONCE LEAKAGE WAS CORRECTED. THERE WAS NO PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112246 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA