BEUDAMED
    FDA Adverse Event Death Summary report: N

    BABYLOG

    MDR report key: 358275 · Received October 25, 2001

    Report

    Report Number
    2517967-2001-00070
    Event Type
    Death
    Date Received
    October 25, 2001
    Date of Event
    September 21, 2001
    Report Date
    October 25, 2001
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: WHILE VENTILATING THE PT IN SIMV WITH VOLUME GUARANTEE, THE USER FELT THE PT WAS RECEIVING EXCESS VOLUME AND THAT THE PT'S CHEST WAS BEING OVEREXTENDED. AN X-RAY WAS TAKEN ON THE DAY OF THE EVENT, AND THE PT WAS NOTED TO HAVE A PNEUMOTHORAX IN ONE LUNG. A CHEST TUBE WAS INSERTED. IT WAS NOTED BY AN X-RAY THAT FOUR DAYS LATER, THE PT HAD A PNEUMOTHORAX IN THE SECOND LUNG. A CHEST TUBE WAS INSERTED. IT WAS REPORTED THAT THE PT LATER EXPIRED. NO AUTOPSY WAS PERFORMED. IT WAS REFUSED BY THE FAMILY. CONCLUSION FROM FACILITY REGARDING PT: INTRAVASCULAR HEMORRHAGE (HEAD) AND PREMATURITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47956 BABYLOG CONTINUOUS VENTILATOR CBK DRAEGER MEDICAL, INC. 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Death