BEUDAMED
    FDA Adverse Event Summary report: N

    REMANUFACTURED 20" RENAISSANCE STERILIZER

    MDR report key: 4122288 · Received September 26, 2014

    Report

    Report Number
    3005899764-2014-00094
    Date Received
    September 26, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 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 FIELD SERVICE TECHNICIAN ARRIVED ONSITE AND INSPECTED THE UNIT. THE TECHNICIAN IDENTIFIED THAT THE SOURCE OF THE LEAK WAS ON THE CONNECTION FOR THE VACUUM WATER LINE. THE TECHNICIAN REPLACED THE CONNECTOR AND THE UNIT WAS TESTED AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR STERILIZER. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600566 REMANUFACTURED 20" RENAISSANCE STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1