BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3111180 · Received April 19, 2013

    Report

    Report Number
    3008355164-2013-00100
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WHILST CONNECTED TO A PT GENERATED TWO TECHNICAL ERROR CODES, ONE INDICATING DISABLE VALVES AND THE OTHER INDICATING AN INTERNAL MEMORY ERROR AND THE VENTILATION CONSEQUENTLY STOPPED. THERE WAS NO PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170722 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI