BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRAGER

    MDR report key: 811779 · Received January 31, 2007

    Report

    Report Number
    MW1041813
    Event Type
    Death
    Date Received
    January 31, 2007
    Date of Event
    May 11, 2006
    Report Date
    July 25, 2006
    Manufacturer
    DRAGER MEDICAL INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CODE BLUE CALLED AT 8:30 AM ON PT IN DAY SURGERY. PT WAS TO UNDERGO A RIGHT TYMPANOPLASTY FOR CHRONIC PERFORATION OF THE RIGHT EAR SECONDARY TO NUMEROUS EAR INFECTIONS. THE PT WAS ON THE OR TABLE UNDER GENERAL ANESTHESIA, WITH PREPARATION TO BEGIN SURGERY WHEN THE PT WENT INTO ASYSTOLE CARDIAC RHYTHM WITH A FEW ESCAPE BEATS. RESUSCITATION MEASURES WERE SUCCESSFUL AND THE PT WAS TRANSFERRED TO THE CRITICAL CARE UNIT. THE PT REMAINED COMATOSE AND DIED FIFTEEN DAYS LATER. THE DRAGER ANESTHESIA MACHINE ALARM WAS NOT HEARD IN THE OR SUITE BY THE OPERATING ROOM TEAM. SAME ANESTHESIA MACHINE WAS USED ON TWO SUCCESSIVE CASES ON EVENT DAY. TAKEN OUT OF OPERATION AT END OF DAY FOR EVENT LOG ANALYSIS BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER DRAGER ANESTHESIA MACHINE BSZ DRAGER MEDICAL INC. NM 6000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death PHILIPS MONITOR V24C MODEL, 438AA