BEUDAMED
    FDA Adverse Event Summary report: N

    REMANUFACTURED 20" CENTURY STERILIZER

    MDR report key: 3897191 · Received June 26, 2014

    Report

    Report Number
    3005899764-2014-00049
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 26, 2014
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE STERILIZER AND CONFIRMED THE CAUSE OF THE LEAK WAS A DAMAGED SIGHT GLASS. THE TECHNICIAN MADE THE REQUIRED REPLACEMENTS, PERFORMED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION. THE STERILIZER WAS INSTALLED IN NOVEMBER OF 2011 AND IS NOT UNDER STERIS SERVICE CONTRACT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR UNIT WAS LEAKING WATER. THE AMOUNT OF WATER WHICH LEAKED WAS APPROXIMATELY ONE GALLON OF WATER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373438 REMANUFACTURED 20" CENTURY STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1