BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 3803105 · Received May 9, 2014

    Report

    Report Number
    2084725-2014-00176
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    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
    VA, US
    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, 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 (10/23/2013 ¿ 04/21/2014) DID NOT REVEAL A SIGNIFICANT TREND. THE COMPLAINT TRENDING FOR PROBLEM CODE ¿ODOR/SMELLS¿ IDENTIFIED A SIGNIFICANT TREND OVER THE PAST 12 MONTHS (MAY 2013 ¿ APRIL 2014). THE HIGHEST RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICAL. THE TRENDING FOR PROBLEM CODE ¿HUMAN REACTION¿ (MAY 2013 ¿ APRIL 2014) REVEALED THE HIGHEST RISK IS CONSIDERED BROADLY ACCEPTABLE. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE RISK OF ODOR AND SMELL EXPOSURE. THE PROBABILITY OF LIKELIHOOD OF INJURY OCCURRING TO THE POPULATION AT RISK OR EXPOSED IS ¿UNLIKELY BUT POSSIBLE.¿ THE SEVERITY IF THE INJURY OR ADVERSE HEALTH OUTCOME THAT MIGHT REASONABLY BE EXPECTED TO OCCUR IS CONSIDERED ¿MODERATE.¿ THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) INDICATES THE RISK ASSOCIATED WITH MILD TO MODERATE HYDROGEN PEROXIDE EXPOSURE THAT DOES OR DOES NOT REQUIRE THIRD PARTY ATTENTION TO PRECLUDE PERMANENT IMPAIRMENT IS "BROADLY ACCEPTABLE." 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.

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. THE ELECTRODE AND CHAMBER PARTS WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON 04/22/2014.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A "SMELL AND ODOR" EMITTING FROM THE STERRAD 100S STERILIZER. ONE HEALTHCARE WORKER (HCW) EXPERIENCED A REACTION OF "CHEST TYPE ISSUES." THE HCW DID NOT SEEK OR RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND IS REPORTED TO BE "FEELING REALLY GOOD." THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF UNTIL IT CAN BE SERVICED. AN ASP 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. (B)(4) ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2014-00176 AND 2084725-2014-00177.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281326 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1