BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMSCO 400 STERILIZER

    MDR report key: 16204459 · Received January 19, 2023

    Report

    Report Number
    3005899764-2023-00002
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 19, 2022
    Report Date
    January 19, 2023
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    UDI-DI
    00724995210991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND NO ISSUES WITH THE FUNCTION OR OPERATION OF THE UNIT. THE TECHNICIAN CHECKED ALL CYCLE PARAMETERS, RAN DART AND LEAK TEST CYCLES AND FOUND TEMPERATURE AND WATER PRESSURE TO ALL BE WITHIN SPECIFICATION. THE TECHNICIAN RETURNED THE STERILIZER TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER IS CONDUCTING AN INVESTIGATION AS A FOLLOW-UP TO "INFLAMMATION" THAT OCCURRED TO A PATIENT POST PROCEDURE. THE USER FACILITY DID NOT DISCLOSE THE CURRENT PATIENT STATUS OR IF ANY MEDICAL TREATMENT WAS ADMINISTERED. WE UNDERSTAND THE USER FACILITY IS REVIEWING ALL THEIR PRE- AND POST-PROCEDURAL STANDARD OPERATING PROCEDURES. THE CUSTOMER CONTACTED STERIS ASKING WE PERFORM AN EVALUATION OF THEIR EQUIPMENT IN AN ATTEMPT TO RULE OUT THE AMSCO 400 STERILIZER AS A CONTRIBUTOR TO THE REPORTED EVENT. THE USER FACILITY DID NOT DISCLOSE THE SPECIFIC INSTRUMENTS THAT WERE USED DURING THE PROCEDURE SUBJECT OF THE REPORTED EVENT. STERIS IS WORKING TO CONDUCT INSPECTION OF THE AMSCO 400 STERILIZER. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INSPECTION IS COMPLETE.

    Description of Event or Problem · 0

    THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING OF THEIR AMSCO 400 STERILIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362942 AMSCO 400 STERILIZER STERILIZER FLE STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STEAM STERILIZER 00724995210991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown