BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1801352 · Received August 16, 2010

    Report

    Report Number
    2084725-2010-00261
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 21, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ASP FSE ASSESSED THE UNIT ONSITE. ONCE THE CUSTOMER'S ELECTRICIAN CORRECTED THE POWER OUTLET PHASE ROTATION, THE FSE CLEANED THE CHAMBER AND REPLACED THE CHAMBER PLASTICS, THE ELECTRODE, THE CHAMBER RACKS AND THE VACUUM CONTROL KIT. THE FSE ALSO VERIFIED THE PROPER OPERATION AND VERIFIED THAT THE PLUG/OUTLET MEETS SPECIFICATIONS. HE RAN SUCCESSFUL SYSTEM AUTO TESTS, A LEAK BACK TEST AND AN EMPTY CHAMBER TEST. THE SYSTEM MEETS SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    IN ORDER TO MEET THE 30-DAY FDA REPORTING REQUIREMENT, THIS COMPLAINT WAS MADE REPORTABLE BASED ON THE INFORMATION AVAILABLE AT THE TIME. AFTER GATHERING ADDITIONAL INFORMATION, THIS COMPLAINT WAS DEEMED NOT REPORTABLE. THE FSE CONFIRMED THERE WAS "NO OBSERVANCE OF HAZE / OIL MIST" AND THE COMPLAINT INVESTIGATION DID NOT FIND ANY EVIDENCE OF HAZE / OIL MIST. THERE WAS NO DEVICE FAILURE.

    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 AND SYSTEM SERIAL NUMBER, HEALTH HAZARD ANALYSIS, AND THE SYSTEM HAZARD USE MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD 100S SYSTEM (SERIAL NUMBER (B)(4)) CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100S DID NOT REVEAL A TREND FOR HAZE / OIL MIST FAILURES. TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD 100S FOUND THERE IS NOT A SIGNIFICANT TREND. TRENDING ANALYSIS FOR PHASE ROTATION ERROR ISSUES ASSOCIATED TO THE STERRAD 100S FOUND THERE IS NOT A SIGNIFICANT TREND. (B)(4). THE PARTS RETURNED FOR INVESTIGATION BY THE ASP FIELD SERVICE ENGINEER WERE CRACKED AND BURNED. INVESTIGATION WAS NOT POSSIBLE. THE ROOT CAUSE OF THE COMPLAINT WAS THE CUSTOMER SERVICED THE UNIT, CHANGING THE STERRAD 100S POWER SUPPLY WITHOUT FIRST CHECKING THE PHASE ROTATION. THIS CAUSED THE VACUUM PUMP TO RUN BACKWARDS; THEREFORE, PRODUCING VACUUM PUMP OIL IN THE CHAMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S STERRAD 100S HAD INCORRECT PHASE ROTATION AT THE POWER OUTLET AND OIL IN THE CHAMBER. THE CUSTOMER CHANGED THE STERRAD 100S POWER SUPPLY WITHOUT CONSULTING WITH AN ASP REPRESENTATIVE. 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 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1