BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVANCE

    MDR report key: 2465253 · Received February 21, 2012

    Report

    Report Number
    2112667-2012-00004
    Event Type
    Injury
    Date Received
    February 21, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    DATEX-OHMEDA INC
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PT INFO IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE SITE. THE SERIAL NUMBER IS UNK AT THIS TIME. THEREFORE, THE MONTH OF MANUFACTURE IS NOT KNOWN.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING INDUCTION, THE CLINICIAN SWITCHED FROM MANUAL VENTILATION TO MECHANICAL VENTILATION. THE CLINICIAN FORGOT TO TURN ON THE FRESH GAS FLOW AND START THE CASE, RESULTING IN NO FLOW OF OXYGEN TO THE PT. THE PT REPORTEDLY BECAME HYPOXIC. THE MONITOR ALARMED FOR LOW SPO2, NOTIFYING THE CLINICIAN OF THE REPORTED CONDITION. THE PT RECOVERED WITH NO INJURY. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA INC

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention