BEUDAMED
    FDA Adverse Event Other Summary report: N

    ORBITER (INTEGRATED)

    MDR report key: 156684 · Received March 13, 1998

    Report

    Report Number
    1423253-1998-00003
    Event Type
    Other
    Date Received
    March 13, 1998
    Date of Event
    February 17, 1998
    Report Date
    February 19, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP
    Product Code
    IYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED, WHILE CAMERA YOKE AT 90 DEGREES, LEHR COLLIMATOR WAS INSTALLED AND LATCHED. PT WAS THEN PUT ONTO ECT BED. CUSTOMER THEN ROTATED CAMERA YOKE CCW TOWARD STUDY START POSITION OF -45 DEGREES. CUSTOMER REPORTED DURING CCW ROTATION AT APPROX -15 TO -20 DEGREES, THE LEHR COLLIMATOR FELL OFF, FIRST STRIKING THE PT IN THE FACE, THEN FALLING TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORBITER (INTEGRATED) GAMMA CAMERA IYX SIEMENS MEDICAL SYSTEMS, INC. NMG GROUP 3535551 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other