BEUDAMED
    FDA Adverse Event Summary report: N

    V-PRO 1 STERILIZER

    MDR report key: 2810258 · Received October 31, 2012

    Report

    Report Number
    3005899764-2012-00080
    Date Received
    October 31, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 31, 2012
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    MLR
    PMA / PMN Number
    K083097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ATTRIBUTED THIS TO USER ERROR, AND REQUESTED A STERIS FIELD SERVICE TECHNICIAN REATTACH THE DOOR PANEL. A STERIS SERVICE TECHNICIAN INSPECTED THE EQUIPMENT, FOUND THAT THE DOOR PANEL AND HARDWARE HAD BEEN REMOVED, AND THEN THE PANEL WAS REINSTALLED WITHOUT HARDWARE. THE PANEL IS HELD IN PLACE BY MAGNETS AND SCREWS. THE SCREWS WERE FOUND NEARBY. THE LOOSE DOOR PANEL IS ATTRIBUTABLE TO IMPROPER REATTACHMENT OF THE PANEL AFTER A PREVENTATIVE MAINTENANCE EVENT. THE STERILIZER DOOR PANEL WAS PROPERLY ATTACHED BY A STERIS SERVICE TECHNICIAN. THE STERILIZER WAS TESTED, FOUND TO BE OPERATIONAL AND RETURNED TO SERVICE. THE CUSTOMER IS AWARE OF THE ISSUE, AND HAS BEEN APPRISED OF PROPER MAINTENANCE PROCEDURES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE DOOR PANEL CAME OFF, FELL ON A STUDENT'S HEAD, AND ROLLED DOWN THE STUDENT'S ARM. THE STUDENT WAS EVALUATED BY A SUPERVISOR AND HOSPITAL RECORD KEEPER. HER BLOOD PRESSURE AND PULSE WERE CHECKED. NO FURTHER TREATMENT WAS ADMINISTERED. SHE RETURNED TO WORK, AND COMPLETED HER SHIFT. NO PROCEDURES WERE DELAYED OR CANCELLED. NO PROPERTY DAMAGE OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1