BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION

    MDR report key: 315451 · Received February 2, 2001

    Report

    Report Number
    9615727-2001-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2001
    Date of Event
    January 22, 2001
    Report Date
    February 1, 2001
    Manufacturer
    SMV INTERNATIONAL
    Product Code
    JWM
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TRANSFORMATION OF A TOMO DATASET FROM VISION INTO INTERFILE IS OK BUT TRANSFORMATION OF THIS INTERFILE INTO ORIGINAL DATASET CHANGE X AND Y VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4417 VISION COMPUTER JWM SMV INTERNATIONAL VISION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA