BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTANA HE 600 SYSTEM

    MDR report key: 9972220 · Received April 17, 2020

    Report

    Report Number
    2028492-2020-00005
    Event Type
    Malfunction
    Date Received
    April 17, 2020
    Date of Event
    March 24, 2020
    Report Date
    December 22, 2020
    Manufacturer
    VENTANA MEDICAL SYSTEMS INC
    Product Code
    KPA
    PMA / PMN Number
    510K EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THROUGH THE CAPA INVESTIGATION, IMPROVEMENTS HAVE BEEN MADE TO THE VENTANA DESIGN PROCESS, INCLUDING DESIGN READINESS AND MATERIAL COMPATIBILITY WORK INSTRUCTIONS AND CHECKLISTS. WE ARE CURRENTLY MONITORING THE PROGRESS OF THE UPDATES MADE TO THE VENTANA DESIGN PROCESSES TO ENSURE EFFECTIVE IMPLEMENTATION. (B)(4).

    Additional Manufacturer Narrative · 1

    THE ROCHE FIELD ENGINEER REPLACED THE AFFECTED PARTS. THE INSTRUMENT HAS BEEN FIXED AND HANDED BACK TO THE CUSTOMER FOR OPERATION. THE DEVICE'S UDI NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE SITE SMELLED A BURNING ODOR COMING FROM THE INSTRUMENT AND THE INSTRUMENT DISPLAYED AN ERROR MESSAGE. THE SITE EVACUATED THE BUILDING AS A PRECAUTION. A ROCHE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND FOUND A PIN-HOLE ON THE T-FITTING THAT CAUSED A SLOW LEAK OF THE HE 600 CLEANING SOLUTION TO THE COMPRESSOR BAY. LIQUID DRIPPED ON THE VENT FAN CONNECTOR AND CREATED AN ELECTRICAL SHORT THAT STOPPED THE FAN. WITHOUT THE FAN WORKING, THE COMPRESSOR OVERHEATED AND THE ELEVATED TEMPERATURE MELTED THE PLASTIC FAN CONNECTOR THAT PRODUCED A BURNING SMELL AND GENERATED THE ERROR MESSAGE. THE ENGINEER INDICATED THERE WAS NO EVIDENCE OF FIRE FOUND AND THERE WAS NO HARM TO ANY USERS ON SITE. THE INSTRUMENT HAS BEEN FIXED AND TESTED BY THE FSE, AND HANDED BACK OVER TO THE CUSTOMER FOR OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435724 VENTANA HE 600 SYSTEM SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1