BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 2991594 · Received March 6, 2013

    Report

    Report Number
    2084725-2013-00118
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 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

    (B)(6).

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PREVENTATIVE MAINTENANCE (PM1) WAS PERFORMED AND THE CATALYTIC CONVERTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, AND SYSTEM HAZARD AND USER MISUSE ANALYSIS. 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 TO (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 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.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED AN EVENT OF A "BURNING SMELL" (ODOR) EMITTING FROM THE STERRAD 100S STERILIZER. HUMAN REACTIONS ARE UNKNOWN AT THIS TIME. ASP WILL CONTINUE TO FOLLOW UP FOR POTENTIAL HUMAN REACTIONS. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. 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) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95413 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101110350

    Patients

    Seq Age Sex Outcome Treatment
    1