BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER MEDICAL TRACH VAC ET TUBES

    MDR report key: 5746381 · Received June 23, 2016

    Report

    Report Number
    1724737-2016-00004
    Event Type
    Malfunction
    Date Received
    June 23, 2016
    Date of Event
    May 20, 2016
    Report Date
    June 22, 2016
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K110269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE MODE BEING EVALUATED FOR ROOT CAUSE. DEVICE NOT RETURNED BY CUSTOMER FOR EVALUATION. DEVICE NOT RETURNED BY CUSTOMER.

    Description of Event or Problem · 1

    PATIENT WAS INTUBATED AND THE ET TUBE OCCLUDED IN THE ER, THEY USED THE ARM OF THE TUBE TO PROP UP THE CIRCUIT. A SUCTION CATHETER WAS CATCHING ON THE SIDES OF THE TUBE. THE OCCLUSION WAS OUTSIDE OF THE PATIENT'S MOUTH. PATIENT ENDED UP GOING TO ICU, AND THE VENTILATOR ALARMED IN TWO DIFFERENT ALARM ZONES. IT WAS APPARENT THE PATIENT WAS NOT GETTING FULLY VENTILATED. THEY TRIED TO USE A TUBE EXCHANGER BUT COULD NOT. THEY TRIED TO PASS A SUCTION CATHETER AND COULD NOT, THEY USED A BRONCHOSCOPE AND FOUND THE TUBE WAS OCCLUDED IN THE ORAL PHARYNX. THEY PULLED THE TUBE AND INTUBATED WITH ANOTHER MANUFACTURERS TUBE. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401283 PARKER MEDICAL TRACH VAC ET TUBES SUBGLOTTIC SUCTION EVAC TUBES BTR PARKER MEDICAL H-PFTVPU-75

    Patients

    Seq Age Sex Outcome Treatment
    1