BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 3171214 · Received June 14, 2013

    Report

    Report Number
    2084725-2013-00235
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: 09/03/2008. 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. ADDITIONAL MANUFACTURER NARRATIVE / CORRECTED DATA: ADDITIONAL SERVICE INFORMATION - OIL WAS REPLACED. THE DHR (DEVICE HISTORY RECORD) 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 ((B)(6) 2012 ¿ (B)(6) 2013) DID NOT REVEAL A SIGNIFICANT TREND. THE COMPLAINT TRENDING FOR PROBLEM CODE ¿ODOR/SMELLS¿ IDENTIFIED A SIGNIFICANT TREND OVER THE PAST 12 MONTHS ((B)(6) 2012 ¿ (B)(6) 2013). THIS RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICAL. THE TRENDING FOR PROBLEM CODE ¿VACUUM SUBSYSTEM FAILURE¿ ((B)(6) 2012 ¿ (B)(6) 2013) REVEALED THE RISK IS CONSIDERED BROADLY ACCEPTABLE. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER ASSOCIATED WITH ¿VACUUM SUBSYSTEM FAILURE¿ IS AT AN ACCEPTABLE LEVEL. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) DEFINES THE RISK AS LOW AS REASONABLY PRACTICAL FOR EXPOSURE TO ODOR OR ODORANTS. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. REVIEW OF THE TRACKING AND TRENDING DATA DID NOT IDENTIFY A TREND. AS A RESULT, ROOT CAUSE OR ASSIGNABLE CAUSE ANALYSIS COULD NOT BE PERFORMED. NO FURTHER ACTION IS REQUIRED; HOWEVER, THIS ISSUE WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. THE CATALYTIC DECOMP FILTER AND OIL MIST FILTER WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(6) 2013.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED AN EVENT OF A "STRANGE ODOR" EMITTING FROM THE STERRAD 100S STERILIZER DURING CYCLES. THERE WAS NO REPORT OF 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) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270570 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101083380

    Patients

    Seq Age Sex Outcome Treatment
    1