BEUDAMED
    FDA Adverse Event Other Summary report: N

    60" CENTURY HC DOMESTIC HINGE

    MDR report key: 1236814 · Received October 30, 2008

    Report

    Report Number
    2515984-2008-00012
    Event Type
    Other
    Date Received
    October 30, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 9, 2008
    Manufacturer
    STERIS MEXICO S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN VISITED THE HOSPITAL TO INVESTIGATE THIS INCIDENT. IT WAS DETERMINED THAT DURING ON SITE INSTALLATION, THE LOWER SERVICE ACCESS PANEL HAD NOT BEEN PROPERLY ALIGNED WITH THE BRACKETS AND MAGNETS THAT SECURE THE ACCESS PANEL. THE ACCESS PANEL WAS ADJUSTED SO THAT THIS WILL NOT RECUR.

    Description of Event or Problem · 1

    THE STERILIZER LOWER SERVICE ACCESS PANEL FELL ON THE INSTRUMENT TECHNICIAN'S LEFT FOOT WHILE LOADING THE STERILIZER. AN X-RAY DETERMINED THAT THE TECHNICIAN'S FOOT WAS NOT BROKEN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE EMPLOYEE IS FINE AND HAS NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60" CENTURY HC DOMESTIC HINGE STERILIZER FLE STERIS MEXICO S. DE R.L. DE C.V. 1112331 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other