BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 300

    MDR report key: 7832363 · Received August 30, 2018

    Report

    Report Number
    8010042-2018-00453
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    March 9, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K970839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 PERON: (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 AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE AIR GAS MODULE REGULATES THE INSPIRATORY AIR GAS FLOW TO THE PATIENT. THE REPORTED FLUCTUATION OF THE O2-CONCENTRATION WAS REPRODUCED DURING SIMULATED USE TEST OF THE RETURNED AIR GAS MODULE IN A REFERENCE VENTILATOR. THE DEVIATION WAS CAUSED BY ONE OF THE PRINTED CIRCUIT(PC) BOARD IN THE AIR GAS MODULE. IF THIS FAULT HAPPENS DURING VENTILATION, THE PATIENT MAY RECEIVE AN AMOUNT OF OXYGEN IN THE GAS MIXTURE THAT DEVIATE FROM THE EXPECTED. FLOW AND PRESSURE MAY ALSO DEVIATE FROM THE EXPECTED. ALARMS WILL BE ACTIVATED IF THE FAILURE OCCURS DURING VENTILATION.

    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

    MANUFACTURER REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672412 SERVO VENTILATOR 300 VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1