BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1172854 · Received September 19, 2008

    Report

    Report Number
    2084725-2008-00588
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE FOUND THE UNIT RUNNING CYCLES, NO PROBLEMS FOUND, ALL PARAMETERS FOUND WITHIN SPECIFICATION, NO ADJUSTMENTS MADE, NO PARTS REPLACED. ASP CUSTOMER CARE ADVISED THE CUSTOMER THAT IT IS NOT RECOMMENDED TO PLACE ITEMS DIRECTLY ON THE RACK WITHOUT A POUCH, WRAP OR TRAY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE WAS REMOVING A LOAD FROM THE STERRAD AND NOTICED A LITTLE DROP OF MOISTURE. THE EMPLOYEE TOUCHED IT TO SEE WHAT IT WAS. SHORTLY AFTER, THE EMPLOYEE'S LEFT INDEX FINGER AND RIGHT MIDDLE AND INDEX FINGER TURNED WHITE, AND BEGAN TO TINGLE. CUSTOMER STATED THAT THE BLADES PLACED IN THE UNIT WERE NOT WRAPPED OR IN POUCHED. THEY WERE PLACED UNCOVERED DIRECTLY ON THE STERRAD RACK. THE EMPLOYEE WENT TO THE EMPLOYEE HEALTH AND NO MEDICATION WAS PRESCRIBED. THE REACTION ON HER SKIN HAS RESOLVED. 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 STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK