BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENERAL ELECTRIC - DATEX OHMEDA

    MDR report key: 747448 · Received October 20, 2005

    Report

    Report Number
    MW1036958
    Event Type
    Other
    Date Received
    October 20, 2005
    Date of Event
    September 12, 2005
    Report Date
    September 26, 2005
    Manufacturer
    DATEX-OHMEDA INC., (GE HEALTHCARE)
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BETWEEN SURGERY PROCEDURES IN MAIN OR, HOSP HAS EXPERIENCED IN 5 ANESTHESIA FAILURES. MACHINE READS "EXPIRED OR INSPIRED REVERSE FLOW." MACHINE WAS PULLED EACH TIME AND MANUFACTURER WAS NOTIFIED. NO PATIENT HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENERAL ELECTRIC - DATEX OHMEDA ANESTHESIA MACHINE BSZ DATEX-OHMEDA INC., (GE HEALTHCARE) 1006-9305-000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other