BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AESPIRE 710

    MDR report key: 4961365 · Received July 30, 2015

    Report

    Report Number
    9710602-2015-00009
    Event Type
    Malfunction
    Date Received
    July 30, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    GE MEDICAL SYSTEMS CHINA CO., LTD.
    Product Code
    BSZ
    PMA / PMN Number
    K000706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 2112667-2013-00005. THE DISTRIBUTOR PERFORMED A CHECKOUT OF THE EQUIPMENT AND NOTED THAT THE FLOW SENSOR WAS CRACKED AND THE FLOW SENSOR DIAPHRAGM WAS STUCK TO THE TOP OF THE FLOW SENSOR HOUSING. FLOW SENSORS OF THIS TYPE ARE CUSTOMER REPLACEABLE, ARE RECOMMEND 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 POSITON. A LEAK CONDITION WILL BE NOTED DURING THE PREOPERATIVE CHECKOUT, AS CONTAINED IN THE AESTIVA USER REFERENCE MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED A LEAK WAS NOTED DURING THE PREOPERATIVE CHECKOUT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498163 AESPIRE 710 ANESTHESIA GAS MACHINE BSZ GE MEDICAL SYSTEMS CHINA CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1