BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCO HEALTHCARE/KENDALL

    MDR report key: 1522985 · Received November 5, 2009

    Report

    Report Number
    MW5013353
    Event Type
    Malfunction
    Date Received
    November 5, 2009
    Date of Event
    September 23, 2009
    Report Date
    October 27, 2009
    Manufacturer
    DAR BREATHING SYSTEM
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGEON PERFORMED A TRACHEOSTOMY (BIVONA TTS BRAND) ON PATIENT IN THE OR UTILIZING THEIR BRONCHOSCOPY CART. A TRACH ADAPTER (8MM) FROM THE BRONCHOSCOPY CART WAS PLACED ON THE PATIENT'S TRACH IN THE OR MATCHING THE SIZE OF THE TRACH. PATIENT ARRIVED IN ICU AND THE SURGEON WAS UNABLE TO REMOVE THE ADAPTER TO PLACE PATIENT ON THE VENTILATOR. SURGEON HAD TO CALL MANAGER OF RESPIRATORY TO ASSIST PRYING THE ADAPTER LOOSE. THIS BRAND ADAPTER WAS ONE USED PREVIOUSLY BY THE PULMONARY LAB ON THEIR BRONCHOSCOPY CART, BUT HAD BEEN DELETED BECAUSE OF THE SAME PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCO HEALTHCARE/KENDALL CONNECTOR DOUBLE SWIVEL W/90DEG PORT BZA DAR BREATHING SYSTEM 0802002283

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other TRACHEOSTOMY BIVONA TTS