BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-U

    MDR report key: 7549283 · Received May 29, 2018

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    Report

    Report Number
    8010042-2018-00267
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Report Date
    September 21, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    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 PERSON: (B)(4).

    Additional Manufacturer Narrative · 0

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE O2 GAS AND THE AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE O2 GAS AND AIR GAS MODULE REGULATES THE INSPIRATORY OXYGEN AND AIR GAS FLOW TO THE PATIENT. THE REPORTED ALARMS FOR HIGH O2-CONCENTRATION WERE NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS AND AIR GAS MODULE IN A REFERENCE VENTILATOR. NO ALARMS WERE GENERATED DURING VENTILATION, NOR ANY DEVIATION DURING TESTS IN THE PRODUCTION TEST SYSTEM. THE DEVICE LOGS HAVE NOT BEEN RECEIVED. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE THE CAUSE COULD NOT BE DETERMINED IN THIS INVESTIGATION. 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)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PATIENT, IT GENERATED ALARMS FOR HIGH 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
    393750 SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1