BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200, SINGLE DOOR

    MDR report key: 2060384 · Received April 15, 2011

    Report

    Report Number
    2084725-2011-00027
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1630-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASP FIELD SERVICE ENGINEER (FSE) REPLACED THE OIL MIST FILTER ASSEMBLY AND CATALYTIC CONVERTER FILTER. THE FSE ALSO REPLACED THE CATALYTIC CONVERTER FILTER TO RESOLVE THE ISSUE. THE ITEMS WERE RETURNED TO ASP FOR EVALUATION. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE, FAILURE MODE EFFECTS ANALYSIS AND THE HEALTH HAZARD EVALUATION. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD 200 SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 200 DID NOT REVEAL A TREND OF HAZE/OIL MIST FAILURES. TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD 200 DID NOT CONSTITUTE A SIGNIFICANT TREND. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED. ALL RISK PRIORITY NUMBER SCORES FOR THE FAILURE OF THIS PART ARE BELOW 100 AND THUS CONSIDERED LOW RISK. THE HHE (HEALTH HAZARD ANALYSIS) RELATING TO HAZE / OIL MIST IS CONSIDERED LOW RISK. THE OIL MIST FILTER WAS RETURNED, TESTED, AND FAILED THE OIL MIST TEST. THE REASON FOR RETURN IS CONFIRMED. THE CATALYTIC CONVERTER WAS RETURNED, TESTED, AND PASSED THE TEST CYCLE. REASON FOR RETURN COULD NOT BE CONFIRMED. BASED ON THE FINDINGS AND REPLACEMENT OF THE OIL MIST FILTER BY THE FSE, THE ISSUE FOR HAZE/OIL MIST WAS RESOLVED.

    Description of Event or Problem · 1

    AN ASP FIELD SERVICE ENGINEER REPORTED THAT WHILE PERFORMING A PLANNED MAINTENANCE, OIL MIST WAS FOUND EMITTING FROM THE EXHAUST FILTER. THERE ARE NO REPORTS OF HARM OR INJURY TO ANY HEALTHCARE WORKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 200, SINGLE DOOR STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1