BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 8061067 · Received November 12, 2018

    Report

    Report Number
    8010042-2018-00604
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    November 2, 2018
    Report Date
    May 9, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 (B)(4). CONTACT PERON: (B)(4). THE REPORTED DEVICE WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER (FSE). THE DEVICE CONTROL PC BOARD WAS REPLACED AND SENT IN FOR INVESTIGATION. OUR INVESTIGATION OF THE RETURNED CONTROL PC BOARD SHOWS THAT THE BOARD IS FAULTY. THE SAME REPORTED ISSUES ARE REPRODUCED DURING OUR TESTING IN LABORATORY ENVIRONMENT. ELECTRICAL MEASURING VERIFIES THAT THE CAUSE WAS DUE TO A COMPONENT ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR "SYSTEM VOLUME TOO SMALL" DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REF. #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901824 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1