BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 7569411 · Received June 5, 2018

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    Report

    Report Number
    8010042-2018-00279
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Report Date
    July 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 AND THE O2 GAS MODULE AND THE AIR GAS MODULE WERE REPLACED AND RETURNED FOR INVESTIGATION. THE O2 GAS MODULE AND THE AIR GAS MODULES REGULATE THE INSPIRATORY GAS FLOW TO THE PATIENT. THE REPORTED FLUCTUATIONS IN O2-CONCENTRATION WERE NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE 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 ARE CONFIRMING THE REPORTED EVENT. THE REPORTED PROBLEM COULD NOT BE REPRODUCED, THEREFORE THE CAUSE COULD NOT BE DETERMINED IN THIS INVESTIGATION.

    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 VENTILATOR HAD FLUCTUATIONS IN O2 CONCENTRATION. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    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
    411090 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1