BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVA

    MDR report key: 3131229 · Received May 23, 2013

    Report

    Report Number
    2112667-2013-00018
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 29, 2013
    Report Date
    May 1, 2013
    Manufacturer
    DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C
    Product Code
    BSZ
    PMA / PMN Number
    K973896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ABILITY TO DELIVER NITROUS OXIDE WITHOUT THE PRESENCE OF OXYGEN. THE ANESTHESIA MACHINE REPORTEDLY ALARMED FOR LOW INSPIRED OXYGEN. THE PATIENT WAS SWITCHED TO ANOTHER OXYGEN SOURCE FOR VENTILATION. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230066 AESTIVA ANESTHESIA MACHINE BSZ DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR