BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA STAINER MODULE

    MDR report key: 2756907 · Received September 24, 2012

    Report

    Report Number
    2028492-2012-00003
    Event Type
    Malfunction
    Date Received
    September 24, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT (SN (B)(4)) HAS BEEN RETURNED FROM THE CUSTOMER SITE AND IS BEING EXAMINED IN DETAIL. THERE IS EVIDENCE OF A SHORT CIRCUIT OF MULTIPLE ELECTRICAL COMPONENTS DUE TO CONTACT WITH FLUIDS. THE ROOT CAUSE OF THE FLUID COMING IN CONTACT WITH THE ELECTRICAL COMPONENTS IS DUE TO A RESTRICTION IN THE WASTE DRAINAGE SYSTEM FROM A BUILD-UP OF DEBRIS.

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE INCIDENT ORIGINALLY REPORTED UNDER 2028492-2012-00003 WAS DETERMINED TO BE A BUILD-UP OF DEBRIS IN THE WASTE FLUID DISCHARGE SYSTEM. A NOTIFICATION HAS BEEN SENT TO CUSTOMERS TO INFORM THEM OF THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR, HOW TO RECOGNIZE IF THE WASTE DISCHARGE SYSTEM IS BECOMING RESTRICTED AND TO REMIND THEM TO PERFORM PERIODIC CLEANING OF THE SYSTEM. A CAPA HAS BEEN OPENED TO PURSUE ADDITIONAL CORRECTIVE ACTION(S).

    Description of Event or Problem · 1

    VENTANA MEDICAL SYSTEMS, INC. RECEIVED A CUSTOMER COMPLAINT REGARDING LABORATORY TECHNICIANS SMELLING BURNING WIRES AND SEEING SMOKE BEING EMITTED FROM A BENCHMARK ULTRA STAINER MODULE. FLUID FROM A SOURCE INTERNAL TO THE BENCHMARK ULTRA INSTRUMENT CONTACTED ELECTRICAL COMPONENTS RESULTING IN A SHORT CIRCUIT EVENT AND ENOUGH HEAT TO CAUSE SOME MELTING OF WIRING INSULATION CAUSING SMOKE TO BE EMITTED. THERE WERE NO SERIOUS INJURIES OR DEATH ASSOCIATED WITH THE INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCHMARK ULTRA STAINER MODULE AUTOMATED SLIDE STAINER KPA VENTANA MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1