BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3081086 · Received April 26, 2013

    Report

    Report Number
    3000251274-2013-00041
    Date Received
    April 26, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 26, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND RAN A DIAGNOSTIC CYCLE AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT; THE SYSTEM 1E CYCLING POWER OFF AND ON. THE CYCLE PRINTOUT SUBJECT OF THE REPORTED EVENT INDICATED A POWER FAILURE BUT THE TECHNICIAN WAS UNABLE TO OBTAIN A COPY OF IT. THE CYCLING OF THE POWER INHIBITED THE OPERATOR FROM RETRIEVING THE INSTRUMENT WHEN PRESSING THE CANCEL BUTTON ON THE SYSTEM 1E. THE TECHNICIAN IDENTIFIED THAT THE UNIT WAS RECEIVING 114.9V FROM CUSTOMER'S SUPPLY AND THE 5V TO REX CONTROLLER INDICATING THE UNIT'S POWER SUPPLY WAS OPERATING PROPERLY. THE TECHNICIAN REPLACED THE REX CONTROLLER AND DC POWER HARNESS AND PERFORMED AN INSPECTING READING AND CONFIRMED THE 5 VOLTS NEEDED TO OPERATE THE CONTROLLER. THE TECHNICIAN PERFORMED SEVERAL DIAGNOSTIC AND PROCESSING CYCLES AND CONFIRMED THE PROCESSOR TO BE OPERATING PROPERLY. STERIS QUALITY REQUESTED THE REX CONTROLLER AND POWER HARNESS BE RETURNED FOR EVALUATION; HOWEVER, THE TECHNICIAN DISCARDED THE COMPONENTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AFTER INITIATING A PROCESSING CYCLE THE SYSTEM 1E BEGAN TO CYCLE POWER OFF AND ON. THE OPERATOR WAS UNABLE TO CANCEL THE CYCLE TO RETRIEVE THE INSTRUMENT FOR APPROXIMATELY 1 HOUR CAUSING A PROCEDURAL DELAY. THE INSTRUMENT WAS PROCESSED IN ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182983 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1