BEUDAMED
    FDA Adverse Event Summary report: N

    42" FLOOR LOADER

    MDR report key: 3170111 · Received June 14, 2013

    Report

    Report Number
    3005899764-2013-00052
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 14, 2013
    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 INSPECTED THE UNIT AND IDENTIFIED THE S2 VALVE REQUIRED REPLACEMENT. HE REPLACED THE VALVE, TESTED THE UNIT AND RETURNED IT TO SERVICE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A FAILED BIOLOGICAL INDICATOR. THE INDICATOR IS NOT A STERIS BRAND BI. NO INSTRUMENTS WERE INVOLVED. NO INJURIES, PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271882 42" FLOOR LOADER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1