BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX-40

    MDR report key: 36219 · Received August 21, 1996

    Report

    Report Number
    1528274-1996-00012
    Event Type
    Malfunction
    Date Received
    August 21, 1996
    Date of Event
    August 1, 1996
    Report Date
    August 1, 1996
    Manufacturer
    SMV AMERICA
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Description of Event or Problem · 1

    A NEW NUCLEAR TECH REMOVED THE COLLIMATOR FROM THE DETECTOR FACE WITH THE SERVER. TECH BARELY INSERTED THE COLLIMATOR INTO THE COLLIMATOR RACK WHEN THE TOP OF THE COLLIMATOR FELL TO THE LEFT OF THE SERVER. TECH CAUGHT THE COLLIMATOR WITH HIS HANDS AND LAID IT ONTO THE BASE OF THE COLLIMATOR SERVER. ANOTHER PERSON ENTERED THE ROOM AND HELPED TECH LIFT THE COLLIMATOR ONTO THE COLLIMATOR RACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FX-40 FX-40 GAMMA CAMERA IYX SMV AMERICA FX-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA