BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESTIVE 7100

    MDR report key: 3830028 · Received March 11, 2014

    Report

    Report Number
    2112667-2014-00041
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 16, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CBK
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    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 2112667-2013-00005. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND NOTED THAT THE FLOW SENSOR DIAPHRAGM WAS STUCK OPEN. 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 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 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 INTO THE STUCK OPEN POSITION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A PREOPERATIVE CHECKOUT OF THE EQUIPMENT, THE SET TIDAL VOLUME WAS NOTED TO BE 500 ML/MINUTE AND DELIVERED TIDAL VOLUME WAS 600 ML/MINUTE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145977 AESTIVE 7100 ANESTHESIA MACHINE CBK DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1