BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION

    MDR report key: 315437 · Received February 2, 2001

    Report

    Report Number
    9615727-2001-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2001
    Date of Event
    January 24, 2001
    Report Date
    February 2, 2001
    Manufacturer
    SMV INTERNATIONAL
    Product Code
    JWM
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER INTERFILE REPORT OPERATION FROM VISION FOR STATIC IMAGES, THE USER CAN'T DISPLAY IMAGE BECAUSE IMAGE DURATION TIME IS ALWAYS EQUAL ZERO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4221 VISION COMPUTER JWM SMV INTERNATIONAL VISION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA