BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION

    MDR report key: 278708 · Received May 9, 2000

    Report

    Report Number
    9615727-2000-00011
    Event Type
    Malfunction
    Date Received
    May 9, 2000
    Date of Event
    April 12, 2000
    Report Date
    May 9, 2000
    Manufacturer
    SMV INTL.
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IMAGE QUALITY IS DRASTICALLY AFFECTED AFTER RESOLUTION RECOVERY AND ATTENUATION CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION COMPUTER JWM SMV INTL. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA