BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH EB ROBERTSHAW LEFT 37F

    MDR report key: 3915382 · Received May 28, 2014

    Report

    Report Number
    8040412-2014-00128
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 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 EVALUATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: WHEN THE PATIENT WAS CONNECTED TO THE RESPIRATOR, THE TRACHEAL CONNECTION OF THE EXCLUSION PROBE BROKE. A NEW EXCLUSION PROBE WAS OPENED TO RECOVER THE TRACHEAL CONNECTION WITHOUT CLINICAL CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314220 RUSCH EB ROBERTSHAW LEFT 37F BTS TELEFLEX MEDICAL 13KT12

    Patients

    Seq Age Sex Outcome Treatment
    1