BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7822889 · Received August 28, 2018

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    Report

    Report Number
    8010042-2018-00448
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 2, 2018
    Report Date
    October 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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

    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). THE VENTILATOR WAS INVESTIGATED ON SITE BY OUR FIELD SERVICE ENGINEER (FSE) AND THE O2 GAS MODULE AND THE AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE O2 GAS MODULE AND THE AIR GAS MODULE REGULATES THE INSPIRATORY OXYGEN AND AIR GAS FLOW TO THE PATIENT. THE REPORTED FLUCTUATING O2 CONCENTRATION WAS NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE AND THE AIR GAS MODULE IN A VENTILATOR. NO ALARMS WERE GENERATED DURING VENTILATION, NOR ANY DEVIATION DURING TESTS IN THE PRODUCTION TEST SYSTEM. NO DEVICE LOG FILES HAVE BEEN RECEIVED. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE THE CAUSE COULD NOT BE DETERMINED IN THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE CONNECTED TO A PATIENT, THE VENTILATOR ALARMED FOR FLUCTUATING O2 CONCENTRATION. 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
    666428 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1