BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3111107 · Received April 9, 2013

    Report

    Report Number
    3008355164-2013-00093
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR WAS CONNECTED TO A PT IT CHANGED PT CATEGORY FROM ADULT TO INFANT AND GENERATED TWO TECHNICAL ERROR CODES. ONE CODE INDICATED DISABLED VALVES AND THE OTHER AN INTERNAL MEMORY ERROR. THE EVENT OCCURRED AT THE SAME TIME AS THE NEBULIZATION WAS STARTED. THE VENTILATOR WAS REPLACED. THERE WAS NOT PT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144748 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI