BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION POWERSTATION

    MDR report key: 54222 · Received December 5, 1996

    Report

    Report Number
    1528274-1996-00025
    Event Type
    Malfunction
    Date Received
    December 5, 1996
    Date of Event
    September 27, 1996
    Report Date
    November 26, 1996
    Manufacturer
    SMV AMERICA
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER MIBI MYOCARD RECONSTRUCTION, THE CUSTOMER THINKS THAT THERE IS A DIFFERENCE BETWEEN THE BOTH RECONSTRUCTED VOLUMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION POWERSTATION COMPUTER JWM SMV AMERICA VISON POWERSTATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *