BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 2891033 · Received December 20, 2012

    Report

    Report Number
    2936999-2012-00690
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS EXPECTED TO BE RETURNED, IF THE SAMPLE IS RETURNED A SUMMARY OF THE SAMPLE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE CUFF WOULD NOT STAY INFLATED DURING PT USE. THIS WAS DISCOVERED DURING TRACH REPLACEMENT PROCEDURE. THE TRACH WAS IN USE FOR THE FULL MONTH. REPLACEMENT WAS PERFORMED WITHOUT INCIDENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY DISPSOABLE CANNULA FENESTRATED LOW JOH COVIDIEN, FORMERLY TYCOHEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1