BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 2223519 · Received July 14, 2011

    Report

    Report Number
    8010042-2011-00133
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED TWO TECHNICAL ERROR CODES INDICATING DISABLED VALVES AND COMMUNICATION FAILURE BETWEEN MONITORING AND BREATHING SUBSYSTEMS. THE VENTILATOR CONSEQUENTLY STOPPED VENTILATING. (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