BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 3171234 · Received June 14, 2013

    Report

    Report Number
    2084725-2013-00267
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PAIN IN EYES.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. METHOD: SERVICE WAS NOT DISPATCHED FOR THIS ISSUE. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, HEALTH HAZARD EVALUATION, 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 (12/07/2012 ¿ 06/05/2013) DID NOT REVEAL A SIGNIFICANT TREND. THE COMPLAINT TRENDING FOR PROBLEM CODE ¿ODOR/SMELLS¿ IDENTIFIED A SIGNIFICANT TREND OVER THE PAST 12 MONTHS (SEPTEMBER 2012 ¿ AUGUST 2013). THE HIGHEST RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICAL. THE TRENDING FOR PROBLEM CODE EYE REACTION¿ (SEPTEMBER 2012 ¿ AUGUST 2013) DID NOT REVEAL A SIGNIFICANT TREND. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR ODOR AND SMELL EXPOSURE AND THE HEALTH/RISK INDEX IS CONSIDERED TO BE NONE/NEGLIGIBLE. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR EYE IRRITATION AND THE ASSOCIATED RISK IS TEMPORARY OR REVERSABLE (A MEDICAL CONDITION WHICH WOULD LIKELY RESOLVE ITSELF AND WHERE MEDICAL TREATMENT IS OPTIONAL) FOR THE OVERALL POPULATION. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) DEFINES THE RISK AS BROADLY ACCEPTABLE FOR EXPOSURE TO HYDORGEN PEROXIDE VAPOR. AS NO SERVICE WAS DISPATCHED FOR THIS ISSUE, 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 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 EMITTING FROM THE STERRAD 100S STERILIZER WHEN A COMPLETED LOAD WAS REMOVED FROM THE CHAMBER. ONE HEALTHCARE WORKER (HCW) EXPERIENCED A REACTION OF A "PAIN IN EYES." THE HCW WASHED THEIR EYES WITH RUNNING WATER AND THE PAIN WAS "HEALED WITHIN ONE DAY." THE HCW DID NOT RECEIVE ANY MEDICAL ATTENTION/TREATMENT. 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
    270861 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 0101105062

    Patients

    Seq Age Sex Outcome Treatment
    1