BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1

    MDR report key: 2863959 · Received December 10, 2012

    Report

    Report Number
    3000251274-2012-00262
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 7, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE EQUIPMENT AND FOUND A SMALL TEAR (APPROXIMATELY AN INCH IN LENGTH) IN THE INFLATABLE LID SEAL. THE SERVICE TECHNICIAN REPLACED THE SEAL, RAN DIAGNOSTIC AND PROCESSING CYCLES AND FOUND THE UNIT OPERATIONAL. THE UNIT WAS RETURNED TO SERVICE. THE PROCESSOR WAS INSTALLED ON (B)(4) 2006, AND LAST SERVICED ON (B)(4) 2012. THE SEAL WAS INSPECTED DURING THE LAST MAINTENANCE EVENT, AND FOUND TO BE IN GOOD CONDITION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER COMING OUT OF THEIR SYSTEM 1 PROCESSOR. THE CUSTOMER ALSO REPORTED A LOUD NOISE PRIOR TO THE EVENT. THE QUANTITY OF WATER COVERED AN AREA APPROXIMATELY 4 X 4 FEET, AND OCCURRED DURING A DIAGNOSTIC CYCLE. THE SPILL WAS CLEANED UP WITH TOWELS AND MOPS.NO INJURIES WERE REPORTED. NO PROCEDURES WERE DELAYED OR CANCELLED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other