BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7985186 · Received October 19, 2018

    Report

    Report Number
    8010042-2018-00552
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 20, 2018
    Manufacturer
    MAGNUS LINDQVIST
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE THERE WAS UNEXPECTED SPIKES NOTED ON THE GRAPH ON THE EXPIRATORY PRESSURE, DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. IMPORTER REF. #: (B)(4); MANUFACTURER REF. #: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS INVESTIGATED BY OUR FIELD SERVICE ENGINEER (FSE). IT WAS NOT POSSIBLE TO DUPLICATE THE REPORTED PRESSURE SPIKES AT END OF INSPIRATION PHASE. NO PARTS WERE REPLACED. THE VENTILATOR PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED FOR CLINICAL USE. THE VENTILATOR LOGS WERE DOWNLOADED FOR FURTHER EVALUATION. THE EVENT LOG CONFIRMS SEVERAL CLINICAL ALARMS, AS AN INDICATION OF DIFFICULTIES WITH VENTILATING THE PATIENT. ON THE OTHER HAND, THE TECHNICAL LOG DID NOT CONTAIN ANY TECHNICAL ERROR CODES THAT COULD INDICATE A MALFUNCTION. THE LOGS ALSO SHOW THAT THE VENTILATOR ALARMS FOR HIGH AIRWAY PRESSURE, PRESSURE DELIVERY RESTRICTED AND EXPIRATORY MINUTE VOLUME LOW. THE FSE INFORMED US THAT THE UNIT WAS RUN ON PRVC MODE. THOSE ALARMS INDICATE THAT THE VENTILATOR WAS FUNCTIONING AND IT ATTEMPTED TO DELIVER THE SET TIDAL VOLUMES, BUT IT FAILED DUE TO THE IMPOSED RESTRICTION OF THE SET UPPER PRESSURE LIMIT. IN PRVC VENTILATION MODE THE VENTILATOR DELIVERS A PRE-SET TIDAL VOLUME AND THE PRESSURE IS AUTOMATICALLY REGULATED TO DELIVER THE PRE-SET VOLUME. THE HIGH PRESSURE ALARM IS GENERATED WHEN THE UPPER PRESSURE LIMIT IS REACHED WHEREBY THE INSPIRATION PHASE IS TERMINATED AND GOES OVER TO EXPIRATION PHASE. THE DIFFICULTIES MAY EITHER BE RELATED TO NOT OPTIMAL PARAMETER SETTINGS OF THE DEVICE FOR THE ACTUAL PATIENT CONDITION OR AN INCREASED EXPIRATORY RESISTANCE. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERE WAS UNEXPECTED SPIKES NOTED ON THE GRAPH ON THE EXPIRATORY PRESSURE, DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. IMPORTER REF. #: (B)(4); MANUFACTURER REF. #: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828236 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAGNUS LINDQVIST

    Patients

    Seq Age Sex Outcome Treatment
    0
    1