BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA

    MDR report key: 2081137 · Received April 14, 2011

    Report

    Report Number
    2112667-2011-00021
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 14, 2011
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MAINTENANCE INSPECTION OF THE MACHINE, THE HOSPITAL REPORTEDLY NOTED NITROUS OXIDE FLOWED WITHOUT THE PRESENCE OF OXYGEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1