BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2903807 · Received January 2, 2013

    Report

    Report Number
    2936999-2012-00730
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 6, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEA
    Product Code
    JOH
    PMA / PMN Number
    K955680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATES: PRIOR TO USE ON A PT, A NURSE AT HOSPITAL HEARD A SOUND OF AIR LEAKAGE FROM THE INFLATION LINE. CUSTOMER CONFIRMED NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324 SHILEY CUFFED PEDIATRIC TRACH TUBE JOH COVIDIEN, FORMERLY TYCOHEA 111200495X

    Patients

    Seq Age Sex Outcome Treatment
    1