BEUDAMED
    FDA Adverse Event Death Summary report: N

    SHILEY

    MDR report key: 5738932 · Received June 21, 2016

    Report

    Report Number
    2936999-2016-00510
    Event Type
    Death
    Date Received
    June 21, 2016
    Date of Event
    March 22, 2016
    Report Date
    January 19, 2017
    Manufacturer
    HENEQUEN-RX
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE: (B)(4). ON 18-JAN-2017, NEW INFORMATION WAS RECEIVED THAT PATIENT EXPIRED. THE PILOT BALLOON BECAME DETACHED AND WAS NOTED AS MISSING. RECANNULATION WAS REQUIRED. MULTIPLE ATTEMPTS TO REESTABLISH AIRWAY VIA TRACHEOSTOMY TUBE WERE NOT SUCCESSFUL. THE PATIENT WAS ORALLY INTUBATED BUT PATIENT CODED AND EXPIRED. THE PATIENT EXPIRED AT 7:52 P.M. ON (B)(6) 2016. THERE IS CURRENTLY NO INFORMATION THAT THE DEATH IS CONSIDERED TO BE RELATED TO ANY FAILURE OF THE DEVICE. THE CUSTOMER WILL NOT BE RETURNING THE TUBE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PILOT BALLOON WAS MISSING FROM THE TRACHEOSTOMY TUBE. THEY WERE NOT AWARE WHERE THE PILOT BALLOON MIGHT BE. NO OTHER INFORMATION (PATIENT INVOLVEMENT/ DATE OF EVENT OR DEVICE RETURN) WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394754 SHILEY DISP.CAN. P-C 8-12.0 BX1 JOH HENEQUEN-RX 8DCT 15H0730J2X

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death