BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISION DS7

    MDR report key: 146508 · Received January 30, 1998

    Report

    Report Number
    1528274-1998-00003
    Event Type
    Malfunction
    Date Received
    January 30, 1998
    Date of Event
    January 26, 1998
    Report Date
    January 30, 1998
    Manufacturer
    SMV AMERICA
    Product Code
    JWM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    AN NMT WAS SETTING UP FOR A TOMO STUDY. THE DETECTOR (RADIUS) MOVED TOO CLOSE TO THE PT, PRESSING AGAINST HIS ARM, BUT HE WAS NOT HURT. NMT HIT THE EMERGENCY STOP SWITCH IN TIME. AT THE TIME, NO SAFETY PAD WAS ON THE DETECTOR. CUSTOMER KNOWS BETTER NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISION DS7 CAMERA JWM SMV AMERICA DS7 S/W 3.14 R3

    Patients

    Seq Age Sex Outcome Treatment
    1 *