BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILLYFLEX

    MDR report key: 35998 · Received August 16, 1996

    Report

    Report Number
    1824231-1996-00009
    Event Type
    Other
    Date Received
    August 16, 1996
    Date of Event
    July 26, 1996
    Report Date
    August 2, 1996
    Manufacturer
    BIVONA MEDICAL TECHNOLOGIES
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VENTILATOR DEPENDENT CHILD WAS SITTING ON A TRAMPOLINE AT HOME, ROCKING BACK AND FORTH. THE VENTILATOR CIRCUIT WAS PULLING ON THE TRACHEOSTOMY TUBE CONNECTION. THE DISTAL PORTION OF THE TUBE SHAFT BROKE AT THE NECKFLANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILLYFLEX TRACHEOSTOMY TUBE, CUSTOM-MADE BTO BIVONA MEDICAL TECHNOLOGIES C5ETTPF604.5063 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR