BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NARKOMED

    MDR report key: 290946 · Received August 16, 2000

    Report

    Report Number
    2517967-2000-00032
    Event Type
    Injury
    Date Received
    August 16, 2000
    Date of Event
    July 24, 2000
    Report Date
    August 16, 2000
    Manufacturer
    DRAEGER MEDICAL, INC.
    Product Code
    BSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: AT THE BEGINNING OF THE CASE, THE USER CONNECTED THE PT TO THE BREATHING CIRCUIT AND THE PRESSURE CLIMBED WITH FRESH GAS BEING APPLIED. EXCESS FRESH GAS WITHIN THE SYSTEM WAS NOT BEING PROPERLY EVACUATED. THE USER THEN EXTUBATED THE PT AND TRIED TO RE-INTUBATE THE PT 3 TIMES UNTIL THEY CHOSE TO CANCEL THE SURGERY. IT WAS DETERMINED BY HOSP PERSONNEL ON SITE THAT THE BREATHING CIRCUIT HAD BEEN INCORRECTLY ASSEMBLED AND A PRE-USE CHECKOUT HAD NOT BEEN PERFORMED PRIOR TO THE OCCURRENCE. THE 22 MM HOSE FROM THE OUTPUT OF THE ULTRA SONIC FLOW SENSOR WAS CONNECTED TO THE VENTILATOR PORT ON THE AUTO/BAG SELECTOR BLOCK INSTEAD OF THE EXPIRATORY VALVE, AND THE 22 MM HOSE FROM THE VENTILATOR BELOW HOUSING WAS ATTACHED TO THE EXPIRATORY VALVE ON THE MACHINE INSTEAD OF THE VENTILATOR PORT ON THE AUTO/BAG SELECTOR BLOCK. THE PT INCURRED A BILATERAL PNEUMOTHORAX. CHEST TUBES WERE PLACED AND THE PT WAS SENT TO INTENSIVE CARE. THE SURGERY WAS PERFORMED AT A LATER DATE. THE PT WAS DISCHARGED FROM THE FACILITY IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NARKOMED ANESTHESIA MACHINE BSZ DRAEGER MEDICAL, INC. NMGS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization