BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIOL SL-200 SCANNING SYSTEM

    MDR report key: 4810849 · Received June 1, 2015

    Report

    Report Number
    1419341-2015-00002
    Event Type
    Malfunction
    Date Received
    June 1, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    LEICA BIOSYSTEMS RICHMOND, INC.
    Product Code
    NTH
    PMA / PMN Number
    K043519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL UNDER INVESTIGATION. FOLLOW UP REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FOLLOWING ISSUES WITH THE ARIOL SL-200 SCANNING SYSTEM: PERSISTENT INCONSISTENCIES IN FRAME ILLUMINATION (CHANGES IN COLOR AND BRIGHTNESS) IN THE SAME SCAN. INCONSISTENCY IN THE COUNT NUMBER OF TARGET EVENTS. VARIABILITY IN OVERALL BRIGHTNESS BETWEEN DIFFERENT SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352362 ARIOL SL-200 SCANNING SYSTEM NONE NTH LEICA BIOSYSTEMS RICHMOND, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1