BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-N

    MDR report key: 8090939 · Received November 20, 2018

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    Report

    Report Number
    8010042-2018-00614
    Event Type
    Malfunction
    Date Received
    November 20, 2018
    Date of Event
    November 8, 2018
    Report Date
    February 25, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K151814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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

    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 WAS REPLACED AND RETURNED FOR INVESTIGATION. THE REPORTED ALARM FOR HIGH O2-CONCENTRATION WAS NOT REPRODUCED DURING TEST OF THE RETURNED O2 GAS MODULE IN A VENTILATOR. NO ALARMS WERE GENERATED DURING VENTILATION, NOR ANY DEVIATION DURING TESTS IN THE PRODUCTION TEST SYSTEM THAT COULD EXPLAIN THE EVENT. NO DEVICE LOGS FROM THE TIME OF THE EVENT HAVE BEEN RECEIVED. THE ROOT CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR GENERATED ALARMS FOR HIGH O2 CONCENTRATION. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    IMPORTER REF. #: CC-CPL-2018-01842. MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932583 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1