BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7519377 · Received May 16, 2018

    Report

    Report Number
    8010042-2018-00242
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    May 8, 2018
    Report Date
    May 31, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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

    OUR FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE VENTILATOR ON SITE AND CONFIRMED THE FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THE NOZZLE UNITS IN THE GAS MODULES WERE REPLACED, THE VENTILATOR PASSED ALL FUNCTIONAL AND SAFETY TESTS AND WAS CLEARED FOR CLINICAL USE. THE NOZZLE UNITS WERE NOT RETURNED FOR INVESTIGATION. THE NOZZLE UNIT IS PART OF THE GAS MODULE AND REGULATES THE INSPIRATORY GAS FLOW TO THE PATIENT. IT CONSISTS OF A MEMBRANE, A MOUTHPIECE AND A FEATHER SPRING. THE MEMBRANE IN THE NOZZLE UNIT IS PRESSED AGAINST A MOUTHPIECE WITH A FEATHER SPRING TO REGULATE THE GAS FLOW THROUGH THE GAS MODULE. SINCE THE NOZZLE UNIT WAS NOT RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THE REPORTED FAILED PRESSURE TRANSDUCER TEST HAS NOT BEEN DETERMINED, BUT THE NOZZLE UNIT WAS MOST LIKELY CONTRIBUTING TO THE EVENT. THE NOZZLE UNIT IS PART OF THE MAINTENANCE KIT FOR THE PRODUCT AND SHALL BE REPLACED YEARLY OR BY MAXIMUM 5000 OPERATING HOURS. IT IS NOT KNOWN TO US WHEN LAST MAINTENANCE WAS PERFORMED. THE CURRENT OPERATING HOURS IS STATED TO BE 23014 HOURS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED PRESSURE TRANSDUCER TEST DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT. (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
    360209 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1