BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1E

    MDR report key: 2822954 · Received October 25, 2012

    Report

    Report Number
    2822954
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 25, 2012
    Manufacturer
    STERIS CORPORATION
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STERILIZING UNIT GIVING A STERILIZATION ERROR; GREATER THAN 4.5 MINUTES IN THE GI LAB. MANUFACTURER REPLACED WATER FILTER CARTRIDGE. SYSTEM NOW OPERATIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1E INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ STERIS CORPORATION 1E *

    Patients

    Seq Age Sex Outcome Treatment
    1 *