BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7973586 · Received October 17, 2018

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    Report

    Report Number
    8010042-2018-00548
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    September 28, 2018
    Report Date
    December 6, 2018
    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 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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS MODULE WAS REPLACED AND RETURNED FOR MANUFACTURE INVESTIGATION. THE REPORTED FLUCTUATING O2 CONCENTRATION WERE REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE MOUNTED IN A VENTILATOR. THE NOZZLE UNIT WAS FOUND TO CAUSING OSCILLATING IN THE O2 GAS MODULE. THE NOZZLE UNIT HAS A PREDETERMINED LIFETIME AND IT IS REPLACED AT PREVENTIVE MAINTENANCE (PM) THAT MUST BE PERFORMED EVERY 5000 HOURS OF OPERATION OR AT LEAST ONCE A YEAR. 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. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE O2 CONCENTRATION WAS FLUCTUATING DURING PATIENT TREATMENT. THERE WAS NO PATIENT HARM. IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (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
    816919 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1