BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 7538441 · Received May 23, 2018

    Report

    Report Number
    8010042-2018-00254
    Event Type
    Malfunction
    Date Received
    May 23, 2018
    Date of Event
    May 15, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NURSE

    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

    THE VENTILATOR WAS INVESTIGATED ON SITE AND THE AIR GAS MODULE WAS REPLACED AND RETURNED FOR INVESTIGATION. THE AIR GAS MODULE REGULATE THE INSPIRATORY AIR GAS FLOW TO THE PATIENT. THE REPORTED FAILURE DURING PRE-USE CHECK WAS REPRODUCED DURING TEST OF THE RETURNED AIR GAS MODULE IN A REFERENCE VENTILATOR. THE FAILURE WAS CAUSED BY A STICKY MEMBRANE IN THE NOZZLE UNIT. 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. THE NOZZLE UNIT HAS A PREDETERMINED LIFETIME AND IS REPLACED AT PREVENTIVE MAINTENANCE (PM) THAT MUST BE PERFORMED EVERY 5000 HOURS OF OPERATION OR AT LEAST ONCE A YEAR. IN THIS CASE THERE IS NO DOCUMENTATION THAT PM HAS BEEN PERFORMED ON A YEARLY BASIS. THE DEVICE LOGS ARE CONFIRMING THE REPORTED EVENT. (B)(4). REF. EXEMPTION #: E2018003. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR DISPLAYED A "SYSTEM VOLUME TOO SMALL" MESSAGE AND FAILED THE INTERNAL LEAKAGE TEST 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
    381935 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1