BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER

    MDR report key: 20246765 · Received September 17, 2024

    Report

    Report Number
    MW5159680
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    September 11, 2024
    Report Date
    September 12, 2024
    Manufacturer
    CARL ZEISS MEDITEC, INC
    Product Code
    OBO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER REPORTED INVALID RESULTS BASED ON OBVIOUS OUT OF RANGE MEASUREMENTS INCLUDING, FOR INSTANCE, AN AVERAGE RNFL (RETINAL NERVE FIBER LAYER) THICKNESS OF 40 UM, AN RNFL SYMMETRY OF "-5%", AND A CUP VOLUME OF 0.0000 MM^3. WITH OBVIOUSLY INVALID INPUTS, REPORTING RESULTS COULD CAUSE IMPROPER INTERVENTION BY THE CLINICIAN, UP TO AND INCLUDING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295340 ZEISS CIRRUS HD-OCT 4000 RETINA TOMOGRAPHER TOMOGRAPHY, OPTICAL COHERENCE OBO CARL ZEISS MEDITEC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other