BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2880187 · Received December 19, 2012

    Report

    Report Number
    3000251274-2012-00267
    Date Received
    December 19, 2012
    Date of Event
    November 30, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EMPLOYEE AT THE FACILITY DISCOVERED THE WATER COMING FROM THE SYSTEM 1E DURING A DIAGNOSTIC CYCLE. THE EMPLOYEE TURNED OFF THE POWER AND WATER SUPPLY TO THE UNIT AND PLACED TOWELS ON THE FLOOR TO CLEAN UP WATER. A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND CONFIRMED THAT WATER WAS COMING FROM THE BOTTOM RIGHT HAND CORNER OF THE UNIT AND IDENTIFIED THAT ONE OF THE LID LATCH SCREWS WAS LOOSE. THE TECHNICIAN TIGHTENED THE LID LATCH SCREW TO SPECIFICATIONS AND REPLACED THE INFLATABLE LID SEAL. A DIAGNOSTIC AND PROCESSING CYCLE WERE RUN AND THE UNIT WAS DEEMED OPERATIONAL AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER WAS COMING FROM THE FRONT OF THE SYSTEM 1E UNIT AND SPILLING ONTO THE FLOOR OF THE GI ROOM. NO REPORT OF INJURY OR PROCEDURAL DELAY/CANCELLATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1