BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS CORPORATION PREVAC STEAM STERILIZER

    MDR report key: 19483995 · Received June 6, 2024

    Report

    Report Number
    MW5155875
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PMS OF 3 STERILIZERS WERE CLOSED OUT SIDE THE MONTH +/- 10 DAY WINDOW FOR COMPLETING SCHEDULED PLANNED MAINTENANCE. THIS WAS DUE TO THE CONTRACTED OEMS INABILITY TO PRODUCE THE PM KITS NEEDED FOR THE EQUIPMENT DUE FOR PM. S/NS: (B)(6). REF REPORTS: MW5155876, MW5155877.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327047 STERIS CORPORATION PREVAC STEAM STERILIZER STERILIZER, STEAM FLE STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown