BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1052931 · Received May 23, 2008

    Report

    Report Number
    2084725-2008-00205
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 26, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE WAS UNABLE TO CONFIRM THE REPORTED ISSUE. HE REPLACED THE INJECTOR VALVE AND THE COMPRESSOR. HE PERFORMED AN EMPTY VALIDATION CYCLE SUCCESSFULLY, AND CONFIRMED ALL PROCESS PARAMETERS WITHIN MFR SPECS. SYSTEM MET REQUIREMENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WHO RECEIVED HYDROGEN PEROXIDE CONTACT ON BOTH HANDS FROM LIQUID DROPS ON THE LOAD. THE CUSTOMER STATED THAT THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. THE ASP FIELD SERVICE ENGINEER WENT TO THE FACILITY TO ASSES THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1