BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3813132 · Received May 15, 2014

    Report

    Report Number
    3000251274-2014-00038
    Date Received
    May 15, 2014
    Date of Event
    April 12, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE HOSE CLAMP REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE HOSE CLAMP, PERFORMED DIAGNOSTIC CYCLES AND RETURNED THE UNIT TO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A SYSTEM 1E HOSE HAD LOOSENED SUBSEQUENTLY ALLOWING WATER TO LEAK ONTO THE FLOOR. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291286 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1