BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1140667 · Received August 28, 2008

    Report

    Report Number
    2084725-2008-00541
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HYDROGEN PEROXIDE CONTACT - CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FIELD ENGINEER CONFIRMED THE VOLTAGE, TEMPERATURE, AND PRESSURE, EACH FUNCTION PERFORMANCE CONFIRMED. THE PLASMA TEST AND LEAKAGE TESTS ALL MET SPECIFICATIONS. TESTS RUN CONFIRMED THE CYCLE COMPLETION WITHOUT ISSUE.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED A CUSTOMER WITH AN EMPLOYEE WHO EXPERIENCED A "BURN". THE EMPLOYEE REPORTED FEELING TINGLING AND PAIN ON THEIR RIGHT INDEX FINGER. THE EMPLOYEE RAN THE "BURN" SITE UNDER RUNNING WATER TO WASH IT OFF. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION OR REQUIRE TREATMENT. PERFORMANCE SERVICE COMPLETED ON 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 UNK