BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANOXOMAT II SYSTEM

    MDR report key: 12244940 · Received July 29, 2021

    Report

    Report Number
    1217058-2021-00001
    Event Type
    Malfunction
    Date Received
    July 29, 2021
    Date of Event
    February 12, 2021
    Report Date
    July 28, 2021
    Manufacturer
    ADVANCED INSTRUMENTS 2 TECHNOLOGY WAY, NORWOOD, MA
    Product Code
    KZJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AJ9023 JAR CAME APART DURING ANAEROBIC CYCLE DUE TO OVER-PRESSURIZATION. JAR TUBE UPDATE KIT WAS SENT TO CUSTOMER ON SO# (B)(4) IN MARCH 2017. THE JAR TUBE UPDATE KIT CONTAINS A PRESSURE RELIEF VALVE WHICH SHOULD BE INSTALLED WITHIN THE JAR TUBE ASSEMBLY, IN ORDER TO PROVIDE PRESSURE RELIEF IN THE EVENT THE GAS PRESSURE IS EVER HIGH ENOUGH TO CAUSE THE JAR TO OVER-PRESSURIZE. THE CUSTOMER DISPOSED OF THE DAMAGED JAR, SO FURTHER INVESTIGATION OF THE ASSEMBLY CANNOT BE PERFORMED. THE CUSTOMER ALSO DID NOT PROVIDE PHOTOS. A FIELD SERVICE ENGINEER WENT ON-SITE ON 19FEB2021 TO ENSURE ALL JAR TUBES IN USE NOW HAVE PRESSURE RELIEF VALVES INSTALLED, THE REST OF THE CUSTOMER JARS ARE NOT DAMAGED, AND THAT THE ANOXOMAT II SYSTEM ITSELF IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    AN AJ9023 JAR CAME APART DURING ANAEROBIC CYCLE DUE TO OVER-PRESSURIZATION. THE JAR WAS SHIPPED TO THE CUSTOMER ON 01 FEB 2013. THE MAINTENANCE AND USE AGREEMENT FOR THE ANOXOMAT JARS STATES THE JARS USEFUL LIFE IS 500 CYCLES OR 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1147372 ANOXOMAT II SYSTEM ANOXOMAT II SYSTEM KZJ ADVANCED INSTRUMENTS 2 TECHNOLOGY WAY, NORWOOD, MA AN2CTS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1