BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB ROBERTSHAW LEFT 37F

    MDR report key: 3955558 · Received June 13, 2014

    Report

    Report Number
    8040412-2014-00143
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 23, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    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 CUSTOMER ALLEGES THAT PRIOR TO INTUBATION, DURING PRE-TESTING, THE TRACHEAL BALLOONS; BOTH DISTAL AND PROXIMAL DEFLATE VERY QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350492 RUSCH EB ROBERTSHAW LEFT 37F ENDOBRONCHIAL TUBE BTS TELEFLEX MEDICAL 13FT12

    Patients

    Seq Age Sex Outcome Treatment
    1