BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZATION SYSTEM

    MDR report key: 1052319 · Received May 22, 2008

    Report

    Report Number
    2084725-2008-00182
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, THE FSE WENT TO THE FACILITY. THE FSE FOUND STABILIZER BUILD UP ON THE VAPORIZER ASSEMBLY. THE FSE INSTRUCTED THE CUSTOMER TO CLEAN THE VAPORIZER ASSEMBLY WITH WATER PERIODICALLY. A NEW VAPORIZER PLATE WAS INSTALLED AND LOOKED "NORMAL". ALL PARAMETERS FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN EMPLOYEE WITH HYDROGEN PEROXIDE CONTACT WHEN REMOVING A WET LOAD FROM THE UNIT. THE CUSTOMER REPORTED THAT THE VAPORIZER PLATE WAS IN PLACE, BUT WAS COVERED IN RESIDUE. THE EMPLOYEE COMPLAINED OF SKIN DISCOLORATION AND TINGLING AT THE CONTACT SITE. THE EMPLOYEE RINSED THE CONTACT AREA UNDER WATER FOR 15 MINUTES AND REPORTED TO THE ER WHERE SHE WAS SEEN AND DISCHARGED WITHOUT FURTHER FOLLOW-UP, NO TREATMENT REPORTED. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZATION SYSTEM STERILIZER MLR ADVANCED STERILIZATION PRODUCTS 10101 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK