BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3250068 · Received July 26, 2013

    Report

    Report Number
    3000251274-2013-00066
    Date Received
    July 26, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 26, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, EVALUATED THE SYSTEM 1E AND FOUND THE CK1 VALVE WAS STUCK IN THE CLOSED POSITION PREVENTING THE WATER IN THE SYSTEM 1E CHAMBER FROM DRAINING. THE TECHNICIAN REPAIRED THE UNIT, RAN A PROCESSING AND DIAGNOSTIC CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER SPILLED OUT OF THE SYSTEM 1E ONTO AN OPERATOR¿S CLOTHING. NO INJURIES WERE REPORTED. THE OPERATOR STATED THE WET CLOTHING WAS AN INCONVENIENCE HOWEVER, NO FURTHER ADVERSE EFFECTS WERE EXPERIENCED. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350906 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1