BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCEL 210 SE

    MDR report key: 3862933 · Received February 20, 2014

    Report

    Report Number
    2112667-2014-00025
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 23, 2014
    Manufacturer
    DATEX-OHMEDA
    Product Code
    BSZ
    PMA / PMN Number
    K863207
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    YEAR OF MANUFACTURE IS 1997; MONTH CANNOT BE DETERMINED. 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. A GE HEALTHCARE SERVICE REP 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 PT. 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 SPECS FOR A MINIMUM OF 3 MONTHS." IN ENGINEERING EVAL, 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 HOSP REPORTED THE UNIT ALARMED FOR APNEA DURING A PREUSE CHECKOUT OF THE MACHINE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106861 EXCEL 210 SE ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA

    Patients

    Seq Age Sex Outcome Treatment
    1