BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAEGER

    MDR report key: 1122487 · Received July 25, 2008

    Report

    Report Number
    1122487
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 25, 2008
    Manufacturer
    DRAEGER MEDICAL AG & CO. KGAA
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING MITRAL VALVE REPAIR/REPLACEMENT AND SINGLE CARDIAC BYPASS GRAFT. CENTAL LINE PLACED AND PT INTUBATED. EASY INTUBATION WITH GOOD VISUALIZATION. PT ON ANESTHESIA MACHINE. DECREASED OXYGEN SATS NOTED, DIFFICULTY VENTILATING, PROBABLE PNEUMOTHORAX FROM CENTRAL LINE INSERTION. L CHEST TUBE INSERTED, PT WENT INTO PEA. CPR INITIATED, MEDS GIVEN, PT RESUSCITATED. PROCEDURE ABORTED, ANESTHESIA MACHINE CHANGED OUT, NO DIFFICULTY WITH REPLACED MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER ANESTHESIA MACHINE BSZ DRAEGER MEDICAL AG & CO. KGAA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization