BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1962043 · Received January 17, 2011

    Report

    Report Number
    2084725-2011-00008
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 5, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-1628-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MANUFACTURE DATE: 02/14/2006. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER AND HEALTH HAZARD ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR THE STERRAD 100S SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100S DID NOT REVEAL A TREND FOR HAZE/OIL MIST. TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD 100S FOUND THERE IS NOT A SIGNIFICANT TREND. THE HHE (HEALTH HAZARD ANALYSIS) RELATING TO HAZE / OIL MIST ISSUES IS CONSIDERED LOW RISK. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. THE ROOT CAUSE OF THE "SMOKE" WAS DETERMINED TO BE THE OIL MIST FILTER AND THE CATALYTIC CONVERTER.

    Additional Manufacturer Narrative · 1

    THE FSE ASSESSED THE UNIT ONSITE. HE REPLACED THE CATALYTIC CONVERTOR, OIL MIST FILTER, AND AN ATM SWITCH. HE RAN DIAGNOSTIC TESTS WHICH PASSED AND RAN AN EMPTY CHAMBER CYCLE WHICH ALSO PASSED.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED THAT WHITE SMOKE WAS COMING OUT OF THEIR STERRAD 100S SYSTEM. THERE WERE NO HUMAN REACTIONS REPORTED AS A RESULT OF THIS EVENT. AN FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1