BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2348587 · Received November 21, 2011

    Report

    Report Number
    MW5023186
    Event Type
    Injury
    Date Received
    November 21, 2011
    Manufacturer
    STERIS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SINCE WE HAVE PURCHASED THE SYSTEM 1E WE HAVE HAD A CONTINUOUS SERIES OF PROBLEMS, RETRO FITS AND UPGRADES. NOW WE ARE TOLD THAT DUE TO MALMANUFACTURING WE WILL NEED TO SERVICE EVERY 90 DAYS NOT 180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E STERILIZER MED STERIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention