BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 7548604 · Received May 29, 2018

    Report

    Report Number
    2438477-2018-00029
    Event Type
    Death
    Date Received
    May 29, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 29, 2018
    Manufacturer
    UNKNOWN
    Product Code
    BYX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A RESPIRATORY ACCESSORY OF 25 FOOT TUBING. (B)(4) WAS NOTIFIED BY THIS EVENT THROUGH A MEDWATCH REPORT NUMBER 101545-2018-00007 WHICH CODES DEVICE ISSUE AS : PROBLEM ASSOCIATED WITH THE USE OF THE DEVICE IN TERMS OF NONCONFORMING TO THAT DEVICE'S INTENDED USE, SPECIFICATIONS, PROCEDURE AND PROCESS OR SERVICE INSTRUCTIONS AND INFORMATION PROVIDED BY THE DEVICE MANUFACTURERS AND AN ADVERSE EVENT (E.G. PATIENT HARM) APPEARS TO HAVE OCCURRED, BUT THERE DOES NOT APPEAR TO HAVE BEEN A PROBLEM WITH THE DEVICE OR THE WAY IT WAS USED. PATIENT EXITED THE CAR UNASSISTED WITH OXYGEN TUBING WRAPPED AROUND HIS LEGS AND SUSTAINED A FRACTURE OF THE RIGHT HIP DUE TO HIS FALL TO THE GROUND. PATIENT WAS TAKEN TO THE HOSPITAL WHERE HE REMAINED UNTIL DEATH TWO DAYS AFTER THE FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391480 DRIVE TUBING BYX UNKNOWN TUB NK 25

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H