BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG

    MDR report key: 2120936 · Received June 3, 2011

    Report

    Report Number
    2120936
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    March 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    DRAGER MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ON VENTILATOR AND PATIENT WAS NOTED TO HAVE 'STACKED' BREATHS (MORE BREATHS THAN REQUIRED BY PATIENT). RESPIRATORY WAS CALLED TO THE BEDSIDE TO TROUBLESHOOT THE VENTILATOR. THE STACKED BREATHS STOPPED, BUT A FEW MINUTES LATER WERE NOTED AGAIN. THE VENTILATOR WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYLOG VENTILATOR, CONTINUOUS, FACILITY USE CBK DRAGER MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DAY