BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK ULTRA PLUS INSTRUMENT

    MDR report key: 20640199 · Received November 8, 2024

    Report

    Report Number
    20640199
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 3, 2024
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON [DATE REDACTED] THE UPS BATTERY FAILED ON THE IMMUNOHISTOCHEMISTRY (IHC) STAINERS CAUSING DISRUPTION IN POWER AND 60 PATIENT SLIDES TO FAIL. THE FAULTY BATTERY BACKUP WAS REMOVED BY BIOMED AND THE FAILED SLIDES HAD TO BE RE-RUN CAUSING DELAY IN RESULTS. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1815153 BENCHMARK ULTRA PLUS INSTRUMENT SLIDE STAINER, AUTOMATED KPA VENTANA MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown