BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER MEDICAL

    MDR report key: 390322 · Received April 23, 2002

    Report

    Report Number
    MW1024806
    Event Type
    Malfunction
    Date Received
    April 23, 2002
    Date of Event
    April 4, 2002
    Report Date
    April 8, 2002
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    APPROX 3.5 HRS INTO THE CASE A GRADUAL ONSET OF INCREASED EFFORT REQUIRED TO VENTILATE THE PT. AFTER REMOVING THE TUBE A SLIGHT KINK IN THE TUBE WAS NOTED. THERE WAS NO AFFECT TO THE PT. WITHIN THE PAST 6 MONTHS, THIS HAS HAPPENED ONE OTHER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARKER MEDICAL TRACHEAL TUBE BTR PARKER MEDICAL * 2001 E - 12E

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR