BEUDAMED
    FDA Adverse Event Other Summary report: N

    BENCHMARK AFM

    MDR report key: 497202 · Received November 20, 2003

    Report

    Report Number
    2028492-2003-00004
    Event Type
    Other
    Date Received
    November 20, 2003
    Date of Event
    November 10, 2003
    Report Date
    November 20, 2003
    Manufacturer
    VENTANA MEDICAL SYSTEMS, INC.
    Product Code
    KPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LIQUID WAS LEAKING FROM INSTRUMENT ONTO THE FLOOR. A TECHNICIAN SLIPPED ON THE LIQUID, BUT WAS NOT INJURED. MEDICAL TREATMENT WAS NOT SOUGHT FOR THE INCIDENT. THE INSTRUMENT MAINTENANCE SCHEDULE HAD BEEN MAINTAINED AND PATIENT CARE WAS NOT EFFECTED. THE INSTRUMENT WAS REPLACED, BUT EVALUATION DOCUMENTATION WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WITH THE RESULTS FROM THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENCHMARK AFM AUTOMATED SLIDE STAINING SYSTEM KPA VENTANA MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other