BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 8020577 · Received October 30, 2018

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    Report

    Report Number
    8010042-2018-00576
    Event Type
    Malfunction
    Date Received
    October 30, 2018
    Report Date
    January 9, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    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 PERSON: (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 (B)(4). CONTACT PERSON:(B)(4). THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE WAS REPLACED AND RETURNED FOR MANUFACTURE INVESTIGATION. THE REPORTED DRIFTING OF O2 CONCENTRATION WERE REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE MOUNTED IN A VENTILATOR. THE DEVIATION WAS CAUSED BY A NOZZLE UNIT IN THE O2 GAS MODULE. IF OSCILLATIONS HAPPEN DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION. EVALUATION OF THE RECEIVED DEVICE LOGS SHOWS THAT DURING THE EVENT THE VENTILATION MODE WAS NEURALLY ADJUSTED VENTILATORY ASSIST(NAVA). THERE ARE FOUR MATCHING EVENTS ON OCTOBER 6, THERE THE FIRST ALARM FOR O2 CONCENTRATION HIGH APPEARING 11:31 AND THE LAST ALARM 22:25.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VENTILATION, THE O2 CONCENTRATION WAS DRIFTING. THERE WAS NO PATIENT HARM. (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861192 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1