BEUDAMED
    FDA Adverse Event Other Summary report: N

    AESTIVA

    MDR report key: 780647 · Received November 2, 2006

    Report

    Report Number
    2112667-2006-00076
    Event Type
    Other
    Date Received
    November 2, 2006
    Date of Event
    April 3, 2006
    Report Date
    November 2, 2006
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY NOTED A SMELL OF N2O. CUSTOMER ALSO REPORTED A HOSPITAL STAFF MEMBER HAD A SPONTANEOUS ABORTION. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AESTIVA ANESTHESIA MACHINE BSZ DATEX-OHMEDA, INC. 0219-1275-550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other