BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ISIS SUBGLOTTIC ET TUBE, 6.0

    MDR report key: 2844706 · Received November 8, 2012

    Report

    Report Number
    3003898360-2012-00518
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 6, 2012
    Report Date
    October 23, 2012
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVAL. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE VENT IS REPORTED AS: THE ET TUBE WOULD NOT DEFLATE PRIOR TO INTUBATION OF A PT. THE ET TUBE WAS BEING PRE-TESTED WHEN THE ALLEGED FAILURE OCCURRED. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON ISIS SUBGLOTTIC ET TUBE, 6.0 ENDOTRACHEAL TUBE BTR TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1