BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3221056 · Received July 3, 2013

    Report

    Report Number
    3008355164-2013-00160
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS CONNECTED TO A PT AND VENTILATING. THE PT SELF-EXTUBATED BUT THE VENTILATOR CONTINUED TO AUTO-TRIGGER/AUTO-CYCLE AND VENTILATE THE 2.5 ET TUBE WITHOUT ALARMING. A CLINICIAN WAS PASSING BY, NOTICED THAT THE PT WAS HOLDING THE ET TUBE IN HIS HAD. THERE WAS NO PT HARM. (B)(4). REF MFR REPORT 8010042-2013-00101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305633 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI