BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 2980679 · Received February 27, 2013

    Report

    Report Number
    2084725-2013-00094
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 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
    JA
    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. THE MESH FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. DEVICE MANUFACTURE DATE: CHANGED FROM UNK TO 08/1997. ADDITIONAL MANUFACTURER NARRATIVE / CORRECTED DATA: UPDATED SERVICE INFORMATION - A PREVENTATIVE MAINTENANCE (PM2) WAS PERFORMED AND THE OIL MIST FILTER WAS REPLACED. 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 TRENDING FOR PROBLEM CODE ¿HUMAN REACTION¿ ((B)(6) 2012 ¿ (B)(6) 2013) REVEALED THE RISK IS CONSIDERED BROADLY ACCEPTABLE. 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 AN "ODOR OF H2O2" EMITTING FROM THE STERRAD 100S STERILIZER. THE CUSTOMER STATES THREE HEALTHCARE WORKERS (HCWS) EXPERIENCED HUMAN REACTIONS. ONE HCW EXPERIENCED "EYE IRRITATION" AND TWO HCWS EXPERIENCED A "DISCOMFORT FEELING." NONE OF THE HCWS RECEIVED MEDICAL ATTENTION/TREATMENT AND ALL SYMPTOMS ARE NOW REPORTED TO BE GONE. 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
    83881 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101973419

    Patients

    Seq Age Sex Outcome Treatment
    1