BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE ENDOSCOPE PROCESSING SYSTEM

    MDR report key: 5014805 · Received August 19, 2015

    Report

    Report Number
    9680353-2015-00052
    Date Received
    August 19, 2015
    Date of Event
    July 27, 2015
    Report Date
    August 19, 2015
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE UNIT, AND IDENTIFIED A LOOSE HOSE CLAMP ON THE HOSE WHICH LED TO THE PRE-FILTER ASSEMBLY. FURTHERMORE THE TECHNICIAN IDENTIFIED THE USER FACILITY'S WATER PRESSURE WAS AT 80 PSI. THE RELIANCE EPS'S WATER PRESSURE SPECIFICATION IS 40 - 50 PSI. THE TECHNICIAN ADJUSTED/LOWERED THE USER FACILITY'S WATER PRESSURE LEVEL. HE ALSO INSTALLED A PRESSURE REGULATOR AND HOSE CLAMPS TO THE AFFECTED AREA AS A PRECAUTIONARY MEASURE TO ACCOMMODATE FOR ANY SPIKES IN PRESSURE LEVELS. THE UNIT SUBJECT OF THE REPORTED EVENT WAS INSTALLED ON (B)(6) 2015 AND IS UNDER STERIS WARRANTY. PER THE EPS INSTALLATION/START-UP CHECKLIST, THE EQUIPMENT/UTILITY REQUIREMENTS INDICATE THE WATER PRESSURE LEVELS WERE WITHIN THE ACCEPTABLE RANGE FOR USE. IT IS UNKNOWN HOW THE USER FACILITY'S WATER PRESSURE RAISED TO ABOVE THE ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A HOSE ON THEIR RELIANCE EPS LOOSENED AND LEAKED WATER. NO REPORT OF INJURY OR PROCEDURAL DELAY OR CANCELLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549984 RELIANCE ENDOSCOPE PROCESSING SYSTEM RELIANCE EPS NZA STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1