BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 6443145 · Received March 29, 2017

    Report

    Report Number
    3007082252-2017-00008
    Event Type
    Death
    Date Received
    March 29, 2017
    Report Date
    March 9, 2017
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    FEB
    PMA / PMN Number
    K983017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    WITH RESPECT TO THIS REPORTED ADVERSE EVENT, THERE HAS BEEN ABSOLUTELY NO FINDING OF WRONGDOING ON THE PART OF CUSTOM ULTRASONICS, INC. IN ADDITION, THERE HAS BEEN ABSOLUTELY NO FINDING OF ANY RELATED FUNCTIONALITY ISSUES WITH THE SYSTEM 83 PLUS 2 AND PLUS 9 AUTOMATED ENDOSCOPE REPROCESSOR ("AER") AND THE AER'S ABILITY PROPERLY REPROCESS ENDOSCOPES.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS DENIED THAT THE SYSTEM 83 PLUS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT AS ALLEGED IN THE LEGAL DCOUMENTS.

    Description of Event or Problem · 1

    IT IS SOLELY ALLEGED, THROUGH LEGAL DOCUMENTS, THAT THE ADVERSE EVENT WAS DEATH. HOWEVER, IT IS BELIEVED THE DEVICE USED AT THIS FACILITY WAS NOT A SYSTEM 83 PLUS DEVICE. INVESTIGATION IS ON-GOING TO THIS EXTENT. IN ADDITION, ALL LIABILITY IS DENIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224968 SYSTEM 83 PLUS ENDOSCOPE WASHER DISINFECTOR FEB CUSTOM ULTRASONICS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death