BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-PRO STERILIZER

    MDR report key: 2130798 · Received June 16, 2011

    Report

    Report Number
    3005899764-2011-00015
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 17, 2011
    Report Date
    June 16, 2011
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    PMA / PMN Number
    K062297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS TECHNICIAN INSPECTED THE STERILIZER, FOUND THE DOOR HEATER CABLE WAS SEVERED, AND OBSERVED EVIDENCE OF ELECTRICAL ARCING ON THE DOOR. THE TECHNICIAN REPLACED THE DOOR HEATER CABLE PLACING IT IN A POSITION TO PREVENT IT FROM RUBBING AGAINST THE DOOR FRAME. THE TECHNICIAN TESTED THE STERILIZER AND PLACED IT BACK INTO SERVICE; NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN A HOSPITAL OPERATOR WAS PREPARING TO LOAD THE STERILIZER, SHE OBSERVED A SPARK COMING FROM THE DOOR, FELT A SMALL SHOCK WHEN THE DOOR HANDLE WAS TOUCHED, AND OBSERVED THAT THE CONTROL PANEL DISPLAY WENT BLANK. THE USER FACILITY REPORTED THE OPERATOR IS FINE AND HAS NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-PRO STERILIZER STERILIZER MLR STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1