BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH ROBERSHAW EB TUBE, RIGHT

    MDR report key: 2972130 · Received February 15, 2013

    Report

    Report Number
    8040412-2013-00040
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 31, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVAL AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE BRONCHIAL CUFF DID NOT INFLATE PROPERLY AND THUS THE RIGHT LUNG COULD NOT BE SEALED. THE TUBE WAS REPLACED. NO REPORT OF A PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69466 RUSCH ROBERSHAW EB TUBE, RIGHT ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1