BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD EQUIPMENT (MLR)

    MDR report key: 1883840 · Received October 27, 2010

    Report

    Report Number
    2084725-2010-00298
    Event Type
    Malfunction
    Date Received
    October 27, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1630-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASP FSE ASSESSED THE UNIT ONSITE. HE FOUND NO CANCELLATION MESSAGES FOR H202 AREA TOO LOW IN THE LAST 15 PLUS CYCLES AND THE LAMP VOLTAGE WAS 1883. THE FSE FOUND THAT THE VACUUM PUMP OIL WAS LOW AND FILLED THE OIL TO THE FILL LINE. HE CLEANED THE EXHAUST FILTER HOUSING, REPLACED THE EXHAUST FILTER AND THE SEAL, AS WELL AS THE UPPER DETECTOR O-RING AND LENS. THE LENSE WAS ETCHED DUE TO USE AND AGE. THE LAMP VOLTAGE IMPROVED TO 4300MV AFTER THE LAMP WAS REPLACED. HE ADDED A LOWER CHAMBER CLEAR LENS AND THE VOLTAGE WAS REDUCED TO 3600MV. THE CUSTOMER RAN A LOADED CYCLE AND THE CYCLE COMPLETED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE, HEALTH HAZARD EVALUATION AND THE FAILURE MODE EFFECTS ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD 200 SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 200 DID NOT REVEAL A TREND FOR "H2O2 AREA TOO LOW" AND "HAZE/OIL MIST." TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD 200 DID NOT CONSTITUTE A SIGNIFICANT TREND. THE HHE (HEALTH HAZARD ANALYSIS) RELATING TO HAZE / OIL MIST IS LOW RISK. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) IS CONSIDERED LOW RISK. THE ROOT CAUSE FOR HAZE/OIL MIST WAS THAT OIL MIST WAS ESCAPING BY THE OIL MIST FILTER. THE ROOT CAUSE FOR H2O2 AREA TOO LOW WAS THAT H2O2 DETECTOR/MONITOR OPTICAL PARTS WERE WORN AND AGED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MISTING OF THEIR STERRAD 200. THERE WERE NO CANCELLATIONS OBSERVED; HOWEVER, THE UNIT DID DISPLAY AN ERROR MESSAGE INTERMITTENTLY FOR THE PAST 3 WEEKS. THERE WERE NO HUMAN REACTIONS REPORTED DUE TO THIS INCIDENT. AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1