BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDALLION STERILIZER

    MDR report key: 536247 · Received March 19, 2004

    Report

    Report Number
    2515984-2004-00001
    Event Type
    Malfunction
    Date Received
    March 19, 2004
    Date of Event
    February 11, 2004
    Report Date
    February 11, 2004
    Manufacturer
    STERIS CORPORATION - ERIE
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERIS RECEIVED A REPORT THAT A 1980 MEDALLION 60" MEDIUM STERILIZER MALFUNCTIONED. THE REPORT INDICATED THAT THE DOOR FAILED DURING THE CYCLE AND OPENED WITH SUFFICIENT FORCE TO DETACH COMPLETELY FROM THE UNIT. THE INCIDENT RESULTED IN PROPERTY DAMAGE TO AN ADJACENT WALL, BUT DID NOT CAUSE ANY INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDALLION STERILIZER STEAM STERILIZER FLE STERIS CORPORATION - ERIE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *