BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6181751 · Received December 16, 2016

    Report

    Report Number
    3004962788-2016-00303
    Event Type
    Death
    Date Received
    December 16, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 6, 2016
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE.

    Description of Event or Problem · 1

    A PATIENT HAD A SUPERDIMENSION ENB PROCEDURE ON (B)(6) 2016. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR A BONE MARROW TRANSPLANT (BMT). TWO DAYS LATER THE PATIENT DEVELOPED A FEVER AND PNEUMONIA WAS SUSPECTED. SUBSEQUENTLY THE PATIENT DIED OF ACUTE HYPOXIC RESPIRATORY FAILURE ON (B)(6) 2016. CAUSE OF DEATH IS REPORTED AS SEPTICEMIA. THE SITE REPORTED THE PATIENT'S DEATH WAS NOT RELATED TO THE SUPERDIMENSION DEVICE OR THE ENB PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831737 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-12

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death