BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 7100

    MDR report key: 4916103 · Received July 15, 2015

    Report

    Report Number
    9710602-2015-00006
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    April 4, 2015
    Report Date
    April 4, 2015
    Manufacturer
    GE MEDICAL SYSTEMS (CHINA) CO., LTD
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY. REFERENCE MDR (B)(4). THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND NOTED THAT THE FLOW SENSOR DIAPHRAGM WAS STUCK TO THE TOP OF THE FLOW SENSOR HOUSING, RESULTING IN THE ALARMS AS REPORTED BY THE CUSTOMER. THE UNIT WILL CONTINUE TO ALARM UNTIL THE FLOW SENSOR IS REPLACED. MANUAL MODE OF VENTILATION IS AVAILABLE TO MAINTAIN VENTILATION OF THE PATIENT. IT WAS ADDITIONALLY NOTED THAT WATER WAS IN THE FLOW SENSOR TUBES. PER THE AESPIRE USER MANUAL, POOLED WATER IN THE SENSOR OR WATER IN THE SENSING LINES CAUSES FALSE ALARMS. THE USER MANUAL PROVIDES SOLUTIONS TO RESOLVE WATER BUILD-UP. 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: (1) A HARD IMPACT, SUCH AS DROPPING THE FLOW SENSOR, OR BY (2) 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. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A PREOPERATIVE CHECKOUT OF THE EQUIPMENT, THE UNIT ALARMED FOR REVERSE FLOW. IT WAS FURTHER NOTED THAT THE SET TIDAL VOLUME WAS 500ML AND DELIVERED TIDAL VOLUME WAS 265ML. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461092 AESPIRE 7100 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS (CHINA) CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1