BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3121718 · Received May 14, 2013

    Report

    Report Number
    3008355164-2013-00116
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER ONE HOUR OF PROPER FUNCTIONING THE VENTILATOR STARTED DELIVERING A HIGHER TIDAL VOLUME THAN SET. THE FOLLOWING PRE-USE CHECK FAILED THE INTERNAL LEAKAGE TEST. THERE WAS NO PT INVOLVEMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212842 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA