BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8322710 · Received February 8, 2019

    Report

    Report Number
    8010042-2019-00079
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 21, 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)(6). THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE). NO FAULT WAS FOUND WITH THE VENTILATOR, ALL TESTS PASSED AND NO PARTS WERE 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. THE FILTER WAS NOT MANUFACTURED OR DISTRIBUTED BY US. THE 1-3 CMH2O PRESSURE SPIKES WERE NOT RELATED TO LEAKAGE AS WAS REPORTED INITIALLY. EVALUATION OF THE RECEIVED DEVICE LOGS SHOW THAT PRE-USE CHECK PRIOR TO AND AFTER THE EVENT WAS SUCCESSFULLY. THERE IS NO ENTRY IN THE TECHNICAL LOG TO INDICATE A TECHNICAL FAILURE IN THE VENTILATOR. AFTER THE USER HAD REMOVED THE FILTER FROM THE INSPIRATORY SIDE NO FURTHER ISSUES HAVE BEEN REPORTED AND THE VENTILATOR HAS BEEN RETURNED BACK INTO 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 PRESSURE SPIKES LEADING TO PEAK PRESSURES RISES OF 2-3 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
    112250 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA