BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1053166 · Received May 28, 2008

    Report

    Report Number
    2084725-2008-00235
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPITAL EQUIPMENT, UNIT EVALUATED AT THE FACILITY. THE FSE FOUND THE INJECTOR PUMP CONNECTION TO BE LOOSE. HE RESEATED THE INJECTOR PUMP CONNECTION AND RAN AN EMPTY CHAMBER CYCLE. THE UNIT MET ALL MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DOOR CLOSED ON AN EMPLOYEE'S LEFT ARM. THE CUSTOMER STATED THAT WHILE THE EMPLOYEE WAS REMOVING A BIOLOGICAL INDICATOR, THE DOOR STARTED CLOSING ON HER ARM. THE EMPLOYEE PRESSED THE CANCEL BUTTON AND THE DOOR OPENED AND RELEASED HER ARM. THE CUSTOMER STATED THAT THE EMPLOYEE WHO EXPERIENCED THIS ISSUE SAW A DOCTOR IN EMPLOYEE HEALTH WHERE SHE HAD AN X-RAY TAKEN THAT SHOWED THAT THERE WAS NO INTERNAL DAMAGE. THE CUSTOMER STATED THAT THE EMPLOYEE WAS DIAGNOSED WITH A "CONTUSION" AND WAS SENT BACK TO WORK. THE CUSTOMER STATED THAT THE EMPLOYEE HAD A BRUISE ON HER ARM. THE CUSTOMER STATED THAT THE EMPLOYEE STATED THAT SHE BELIEVED THAT THE EMPLOYEE BELIEVES THAT SHE ACCIDENTALLY PRESSED THE START BUTTON WHILE SHE WAS REACHING INTO THE CHAMBER. THE CUSTOMER STATED THAT SHE ALREADY IN-SERVICED THE EMPLOYEES TO DO THIS. THE FSE WENT TO THE FACILITY TO REPAIR 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 59 YR