BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIA T, T2, T6, T16

    MDR report key: 2143700 · Received May 9, 2011

    Report

    Report Number
    1423253-2011-00001
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 24, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA INC. MI GROUP
    Product Code
    IYX
    PMA / PMN Number
    K082506
    Removal / Correction Number
    1423253-05/27/2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PRODUCT PROBLEM WAS DISCOVERED DURING INTERNAL RELEASE TESTING. THE RADIATION THERAPY PALLET IS WIDER THAN THE NORMAL PALLET AND FLAT. WITH A SMALL PATIENT, ON THE PALLET AND THE CAMERA CONTOURING AROUND THE LEGS (THE THINNEST PART OF THE PATIENT), THE LIGHT RAILS MAY NOT DETECT THE PATIENT DUE TO THE ANGLE AT WHICH THE DETECTOR COMES AROUND THE EDGE OF THE PALLET. IN THIS CASE, THE PRODUCT BEHAVIOR IS AS IF THERE WAS NO PATIENT ON THE PALLET AT ALL. IN THIS CASE, AN INJURY MAY OCCUR IF THE DETECTOR MAKES CONTACT WITH A PATIENT ON THIS PALLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIA T, T2, T6, T16 GAMMA CAMERA IYX SIEMENS MEDICAL SOLUTIONS USA INC. MI GROUP 08717733

    Patients

    Seq Age Sex Outcome Treatment
    1