BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATEX OHMEDA GAS MACHINE ANESTHESIA

    MDR report key: 5778288 · Received July 5, 2016

    Report

    Report Number
    MW5063285
    Event Type
    Injury
    Date Received
    July 5, 2016
    Report Date
    July 5, 2016
    Manufacturer
    DATEX OHMEDA, INC.
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BIOMED/TRIMEDX PERFORMED THE YEARLY (PRN) TEST ON ANESTHESIA MACHINES. IN THE PROCESS OF PERFORMING THIS MAINTENANCE, A BLACK MOLD LOOKING SUBSTANCE WAS DISCOVERED ON THE INSIDE OF THESE MACHINES. THIS EVENT WAS RELAYED ON THE GE COMPANY, REP, FIELD MANAGER TO DISCUSS THESE CONCERNS. MFR EDUCATIONAL, GUIDANCE, MATERIALS AND MANUALS WERE LIMITED AND EVEN MISSING SECTIONS OF THE INSTRUCTION MANUAL. THEY ARE VERY LIMITED IN REGARD TO CLEANING TECHNIQUES NECESSARY, OR ANY OTHER INSTRUCTION TO PREVENT "MOLD APPEARING" OR AFTER FROM REAPPEARING. WITHOUT ANY PRIOR KNOWLEDGE OR TRAINING WE ARE NOW IMPLEMENTING A PROCESS TO STERILIZE THESE PIECES MORE FREQUENTLY ON A QUARTERLY BASIS AND AS NEEDED PER PT CONDITION. IN ADDITION WE HAVE ADDED SPECIAL FILTERS TO REDUCE THE MOISTURE IN THE BREATHING CIRCUITS DURING EASE USE. WORKED WITH INFECTION CONTROL NURSE AND DID AN ENVIRONMENTAL CULTURE ON AN ANESTHESIA MACHINE (FUNGAL). THE RESULTS AFTER 4 WEEKS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424783 DATEX OHMEDA GAS MACHINE ANESTHESIA ANESTHESIA MACHINES BSZ DATEX OHMEDA, INC. AVAME CS2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention