BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2223401 · Received June 17, 2011

    Report

    Report Number
    8010042-2011-00106
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 11, 2009
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AIR GAS MODULE WAS NOT RETURNED FOR INVESTIGATION. THE EVAL OF THE VENTILATOR LOGS SHOWED THAT THE PRESSURE TRANSDUCER TEST AND THE SAFETY VALVE TEST FAILED DURING PRE-USE CHECK. BASED ON THE EVAL OF THE LOGS, THE MOST PROBABLE CAUSE OF THESE FAILURES WAS A STICKY MEMBRANE IN THE NOZZLE UNIT MOUNTED IN THE AIR GAS MODULE. THE CAUSE OF THE STICKINESS IS WEAR OF THE MEMBRANE. THE REPORTED INTERNAL LEAKAGE TEST FAILURE COULD NOT BE CONFIRMED IN THE VENTILATOR LOGS. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR FAILED THE INTERNAL LEAKAGE TEST DURING PRE-USE CHECK. (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