BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH REINFORCED ENDOTRACHEAL TUBE, 8.0MM

    MDR report key: 2171421 · Received June 29, 2011

    Report

    Report Number
    9610520-2011-00007
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    June 20, 2011
    Manufacturer
    WILLY RUESCH GMBH
    Product Code
    BTR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING PRE-TESTING AND BEFORE USAGE THE CUFF COULD NOT BE INFLATED. THE INFLATION TUBE WAS KINKED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSCH REINFORCED ENDOTRACHEAL TUBE, 8.0MM ENDOTRACHEAL TUBE BTR WILLY RUESCH GMBH NA 11091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA