BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANOXOMAT MARK II

    MDR report key: 867575 · Received May 29, 2007

    Report

    Report Number
    867575
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    October 31, 2006
    Report Date
    May 29, 2007
    Manufacturer
    SPIRAL BIOTECH, INC.
    Product Code
    KZB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS SET UP AND TESTED. CATALYST SUPPLIED WOULD NOT PRODUCE ANAEROBIC CONDITIONS IN CANNISTERS. MANUFACTURER TECHNICAL SUPPORT SUGGESTED ORDERING MORE CATALYST. ORDERED IN NOVEMBER, DECEMBER AND JANUARY. WOULD NOT PASS QC. IN FEBRUARY MANUFACTURER REQUESTED RETURN OF THE DEVICE FOR EVALUATION. RETURNED TO USER IN MARCH WITH NO PROBLEMS FOUND. CATALYSTS CONTINUED TO FAIL. IN APRIL NOTIFIED BY MANUFACTURER THAT BAD CATALYST MAY HAVE BEEN RELEASED. MANUFACTURER PROMISED CERTIFIED CATALYST. NONE RECEIVED. UNIT NOT USABLE AFTER SEVEN MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANOXOMAT MARK II CULTURE SYSTEM, ANAEROBIC KZB SPIRAL BIOTECH, INC. MARK II *

    Patients

    Seq Age Sex Outcome Treatment
    1 *