BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 2945407 · Received February 1, 2013

    Report

    Report Number
    9611710-2013-00062
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    February 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K080821
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE AVAILABLE INFORMATION THIS IS DEEMED TO BE A SERIOUS MALFUNCTION. THE ENDOTRACHEAL TUBE VENTILATOR ADAPTER DISCONNECTS EASILY FROM THE VENTILATOR. THIS COULD TO LEAD TO A SERIOUS ADVERSE EVENT. THE PATIENT WILL NOT BE ADEQUATELY OXYGENATED IF THE DELIVERY SYSTEM IS NOT FUNCTIONING AS INTENDED. RESPIRATORY DECOMPENSATION COULD PUT THE PATIENT AT RISK FOR HEMODYNAMIC INSTABILITY. ADDITIONALLY, THERE ARE RISKS INVOLVED IN EXTUBATING AND REINTUBATING (WITH A NEW DEVICE) A PATIENT WHO REQUIRE MECHANICAL VENTILATION AND IS NOT CAPABLE BREATHING ON THEIR OWN. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    (B)(4). THE COMPLAINT WAS RECEIVED BY (B)(4) ON (B)(4) 2012 FROM (B)(6) FOR PRODUCT ENDOTRACHEAL (PAEDIATRIC) TUBE SIZE 3.5MM. CUSTOMER COMPLAINING: "THE CONNECTOR OF THE GREEN ENDOTRACHEAL TUBE GOT DISCONNECTED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43765 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TUBE, TRACHEAL BTR UNOMEDICAL SDN BHD 35112 608230R003

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening