BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCEL SE

    MDR report key: 1140930 · Received August 28, 2008

    Report

    Report Number
    2112667-2008-00037
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 28, 2008
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K863207
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT WAS INTUBATED AND VENTILATION WAS IN A BAG MODE POSITION. AT SOME POINT, CLINICIAN SWITCHED TO MECHANICAL MODE OF VENTILATION. HIGH PRESSURE WAS REPORTEDLY DELIVERED TO THE PT, RESULTING IN DAMAGE TO THE PT'S LUNGS. HOSPITAL STAFF REPORTEDLY NOTED A TEST PLUG ON THE 17MM DRIVE GAS HOSE OUTLET. INVESTIGATION / CONCLUSION: THE HOSP HAS REFUSED GE HEALTHCARE ACCESS TO THE MACHINE, AND HAS DECLINED TO PROVIDE FURTHER INFO. FURTHER INVESTIGATION INTO THE EXACT ROOT CAUSE OF THE REPORTED EVENT CANNOT BE PERFORMED UNTIL ACCESS IS GRANTED AND/OR ADDITIONAL INFO CAN BE OBTAINED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCEL SE ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention