BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANCE

    MDR report key: 3368352 · Received September 11, 2013

    Report

    Report Number
    2112667-2013-00045
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 16, 2013
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K032803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 2111667-2013-00005. FLOW SENSOR OF THIS TYPE ARE CUSTOMER REPLACABLE, 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 SENOR (PLASTIC). UNDER TYPICAL USE, THE SENOR MEETS SPECIFICATIONS FOR A MINIMUM OF 3 MONTHS." A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN ENGINEERING EVALUATION, THE STUCK DIAPHRAGM HAS BEEN ABLE TO BE REPRODUCED BY: A HARD IMPACT, SUCH AS DROPPING THE 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 SI 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 INTO THE STUCK OPEN POSITION.

    Description of Event or Problem · 1

    DURING A SERVICE VISIT, SERVICE REPRESENTATIVE NOTED THE FLOW SENSOR DIAPHRAGM WAS STUCK OPEN. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456562 AVANCE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1