BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1935523 · Received December 22, 2010

    Report

    Report Number
    2084725-2010-00316
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1631-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASP FSE ASSESSED THE UNIT ONSITE. UPON ARRIVAL THE SYSTEM WAS FUNCTIONING AS DESIGNED; THERE WERE NO FAILED CYCLES. HE REPLACED THE OIL MIST FILTER ASSEMBLY, TESTED ITS FUNCTIONALITY AND IT WAS OPERATING WITHOUT ISSUES. HE RAN SEVERAL TEST CYCLES AND THE UNIT MEETS THE MANUFACTURERS' REQUIREMENTS. THE SYSTEM HAS BEEN TURNED OVER TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE: 11/2005. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE, AND THE HEALTH HAZARD EVALUATION. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD NX SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD NX DID NOT REVEAL A TREND OF HAZE/OIL MIST FAILURES. TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD NX DID NOT CONSTITUTE A SIGNIFICANT TREND. THE HHE (HEALTH HAZARD ANALYSIS) RELATING TO HAZE / OIL MIST IS LOW RISK. THE ROOT CAUSE WAS THE OIL MIST FILTER WAS FULLY SATURATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S STERRAD NX WAS EMITTING OIL MIST. THERE WERE NO REPORTS OF HUMAN REACTIONS DUE TO THIS EVENT. AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1