BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENCHMARK XT

    MDR report key: 5690247 · Received May 31, 2016

    Report

    Report Number
    2028492-2016-00002
    Event Type
    Malfunction
    Date Received
    May 31, 2016
    Date of Event
    May 2, 2016
    Report Date
    May 31, 2016
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC
    Product Code
    NQN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NA.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER SLIPPED OVER LCS (OIL) THAT LEAKED FROM THE INSTRUMENT. HE SUFFERED A BRUISED RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344208 BENCHMARK XT NQN VENTANA MEDICAL SYSTEMS, INC 750-700 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1