BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 4241850 · Received November 10, 2014

    Report

    Report Number
    2084725-2014-00355
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-1026-1027-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS, AND SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR WAS REVIEWED AND INDICATED NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCED "ODOR/SMELLS" ISSUE. THE UNIT MET SPECIFICATION AT THE TIME OF ITS RELEASE. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST 6 MONTHS (04/23/2014 ¿ 10/20/2014) DID NOT REVEAL A SIGNIFICANT TREND. THE TREND OF THE PRODUCT MALFUNCTION CODE "ODOR/SMELLS" WAS COMPLETED FROM NOBEMBER 2013 THROUGH OCTOBER 2014 AND DID NOT REVEAL A SIGNIFICANT TREND. THE FMEA REVEALED THE RISK PRIORITY NUMBER ASSOCIATED WITH ¿OIL ODOR/SMELL¿ IS AT AN ACCEPTABLE LEVEL. THE SHUMA DEFINES THE RISK AS BROADLY ACCEPTABLE FOR MILD TO MODERATE EXPOSURE TO VAPOR HYDROGEN PEROXIDE. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND FOR THIS STERILIZER. AS A RESULT, ROOT CAUSE OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PREVENTATIVE MAINTENANCE WAS PERFORMED AND THE CATALYTIC DECOMP FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE SYSTEM RISK ANALYSIS (SRA) SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." CORRECTED DATA: CORRECTING ASSIGNABLE CAUSE STATEMENT FROM: " AS A RESULT, ROOT CAUSE OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED." TO "THE ASSIGNABLE CAUSE OF THE ODOR/SMELLS ISSUE IS THE REPLACEMENT FILTER. THE FIELD SERVICE ENGINEER REPLACED THIS PART AND CONFIRMED THE STERRAD® 100S WAS RESTORED TO PROPER FUNCTION AFTER SERVICE."

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED AN EVENT OF AN "ODOR" EMITTING FROM THE STERRAD® 100S STERILIZER. THERE WAS NO REPORT OF ANY HUMAN REACTION. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723406 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 984265

    Patients

    Seq Age Sex Outcome Treatment
    1