BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 3820661 · Received April 10, 2014

    Report

    Report Number
    2112667-2014-00060
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 18, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(4) LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST TWO YEARS. REFERENCE MDR 2112667-2013-00005. THE UNIT WILL CONTINUE TO ALARM UNTIL THE FLOW SENSOR IS REPLACED. MANUAL MODE OF VENTILATION IS AVAILABLE TO MAINTAIN VENTILATION OF THE PATIENT. FLOW SENSORS OF THIS TYPE ARE CUSTOMER REPLACEABLE, ARE RECOMMENDED FOR REPLACEMENT AFTER 3 MONTHS, AND ARE WARRANTED FOR 6 MONTHS. THE MAINTENANCE SCHEDULE IN THE USER REFERENCE MANUAL STATES: "REPLACE THE DISPOSABLE FLOW SENSOR (PLASTIC). UNDER TYPICAL USE, THE SENSOR MEETS SPECIFICATIONS FOR A MINIMUM OF 3 MONTHS." IN ENGINEERING EVALUATION, THE STUCK DIAPHRAGM HAS BEEN ABLE TO BE REPRODUCED BY: A HARD IMPACT, SUCH AS DROPPING TH E FLOW SENSOR, OR BY STICKING AN OBJECT INTO THE FLOW SENSOR, CAUSING THE DIAPHRAGM TO STICK OPEN. IF A SENSOR IS SUBJECTED TO A HARD IMPACT, IT IS STILL UNLIKELY THAT THE DIAPHRAGM WILL GET STUCK IN THE OPEN POSITION. THIS FAILURE MODE REQUIRES AN IMPACT IN A VERY LIMITED ORIENTATION TO RESULT IN THE INERTIA NEEDED TO FORCE THE DIAPHRAGM IN THE STUCK OPEN POSITION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THE ANESTHESIA MACHINE ALARMED FOR A FLOW SENSOR FAILURE DURING A CASE. THE PATIENT WAS SPONTANEOUSLY BREATHING, AND THE CASE WAS COMPLETED WITH NO FURTHER REPORTED COMPLAINT. FOLLOWING THE CASE, THE HOSPITAL REPLACED THE EXPIRATORY FLOW SENSOR AND NOTED THAT THE DIAPHRAGM WAS STUCK OPEN. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216537 AVANCE ANESTHESIA MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1