BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNA-CLAVE STERILIZER

    MDR report key: 2852380 · Received November 13, 2012

    Report

    Report Number
    1017522-2012-00026
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    PELTON & CRANE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAGNA-CLAVE STERILIZER IS A MANUALLY OPERATED DEVICE REQUIRING THE OPERATOR TO MONITOR THE STERILIZER DURING THE STERILIZING CYCLE INCLUDING CHANGING THE STERILIZER FROM "STERILIZE" TO "VENT" WHEN THE BUZZER ACTIVATES AT THE END OF THE STERILIZATION CYCLE INDICATING THE STERILIZATION CYCLE IS COMPLETE. WHILE THE STERILIZER IS IN THE "STERILIZE" MODE THE "HEAT ON" LIGHT WILL ILLUMINATE INDICATING THE MAIN HEATING ELEMENTS ARE ENERGIZED AS DOCUMENTED IN THE OPERATORS MANUAL. THE MAINTENANCE DEPARTMENT FROM THE USER FACILITY INFORMED PALTON & CRANE THE EVENT OCCURRED AS A RESULT OF USER ERROR BECAUSE THE OPERATOR DID NOT FOLLOW THE MAGNA-CLAVE OPERATING INSTRUCTIONS AS WELL AS ADHERE TO THE "WARNING" ON THE STERILIZER REGARDING THE IMPROPER OPERATION OF THE DEVICE. INSTEAD THE OPERATOR STARTED A STERILIZATION CYCLE AND LEFT THE STERILIZER RUNNING UNATTENDED IN THE "STERILIZE" MODE OVER THE WEEKEND AND DID NOT PROPERLY VENT THE STERILIZER AT THE END OF THE STERILIZATION CYCLE WHICH IN TURN DEACTIVATES THE MAIN HEATING ELEMENTS.

    Description of Event or Problem · 1

    THE OPERATOR OF A MAGNA-CLAVE STERILIZER STARTED A STERILIZING CYCLE ON FRIDAY EVENING AND LEFT THE STERILIZER RUNNING ON THE "STERILIZE" MODE OVER THE WEEKEND. WHEN THE FACILITY OPENED UP ON MONDAY MORNING THE OPERATOR OPENED THE DOOR TO THE STERILIZER AND SMOKE CAME OUT OF THE STERILIZER CHAMBER AND SET OFF THE SMOKE DETECTOR. THE INSTRUMENT INSIDE THE STERILIZER CHAMBER HAD BURNED. THERE WERE NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNA-CLAVE STERILIZER STERILIZER FLE PELTON & CRANE A6

    Patients

    Seq Age Sex Outcome Treatment
    1