BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2223444 · Received June 17, 2011

    Report

    Report Number
    8010042-2011-00116
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    January 28, 2010
    Report Date
    May 20, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED AIR GAS MODULE WHICH REGULATES THE INSPIRATORY AIR GAS FLOW TO THE PT WAS INVESTIGATED. THE REPORTED HIGH OXYGEN CONCENTRATION ALARM DURING VENTILATION WAS NOT REPRODUCED. THE TESTS PERFORMED ON THE AIR GAS MODULE REVEALED THAT THE MEMBRANE IN THE NOZZLE UNIT MOUNTED IN THE AIR GAS MODULE WAS STICKY WHICH WAS THE MOST PROBABLE CAUSE OF THE REPORTED FAILURE. THE NOZZLE UNIT, WHICH IS PART OF THE GAS MODULE AND CONSISTS OF A MEMBRANE, A MOUTHPIECE AND A FEATHER SPRING, IS USED FOR REGULATION OF THE GAS FLOW THROUGH THE GAS MODULE. 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 MEMBRANE STICKINESS MAY CAUSE THE FEATHER SPRING TO GET STUCK TO THE MEMBRANE WHILE BEING PRESSED ONTO IT AND THUS CAUSING A DELAY ON RELEASE. THE DELAY AFFECTS THE REGULATION OF THE GAS FLOW THROUGH THE GAS MODULE AND CAUSES FAILURE DURING PRE-USE CHECK AND, DURING VENTILATION, CAUSES THE DELIVERED GAS FLOW AND PRESSURE TO BE HIGHER THAN SET. A FEATHER SPRING WITH A COARSE SURFACE WAS INTRODUCED IN (B)(6) 2010 TO PREVENT IT FROM GETTING STUCK TO THE MEMBRANE. THE CAUSE TO THE STICKINESS IS WEAR OF THE MEMBRANE IN NOZZLE UNIT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR ALARMED FOR HIGH OXYGEN CONCENTRATION WHILE IT WAS CONNECTED TO A PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1