BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIANCE EPS

    MDR report key: 12953557 · Received December 7, 2021

    Report

    Report Number
    9680353-2021-00046
    Event Type
    Malfunction
    Date Received
    December 7, 2021
    Date of Event
    November 8, 2021
    Report Date
    December 7, 2021
    Manufacturer
    STERIS CANADA ULC
    Product Code
    NZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE HOT WATER HOSE HAD DISCONNECTED FROM ITS FITTING ALLOWING WATER TO LEAK OUT ONTO THE FLOOR. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE USER FACILITY'S HOT WATER EXCEEDING THE RELIANCE EPS WATER TEMPERATURE SPECIFICATIONS. THE HIGH TEMPERATURE CAUSED THE HOSE TO EXPAND AND DISCONNECT FROM ITS FITTING. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF ENSURING THE WATER IS WITHIN SPECIFICATIONS. THE TECHNICIAN REPLACED THE HOSE, TESTED THE UNIT, CONFIRMED IT WAS OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED WATER LEAKING FROM THEIR RELIANCE EPS ONTO THE FLOOR. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846432 RELIANCE EPS ENDOSCOPE PROCESSING SYSTEM NZA STERIS CANADA ULC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown