BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3102399 · Received April 30, 2013

    Report

    Report Number
    2936999-2013-00326
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PRETESTING OF THE TUBE AN AIR LEAKAGE WAS PRESENTED IN THE CUFF. THE CUSTOMER CONFIRMED NO PT INVOLVEMENT. THE CUSTOMER DID NOT PROVIDE/CONFIRM ANY ADD'L INFO RELATED TO PRETESTING EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187364 SHILEY FENESTRATED LOW PRESSURE CUFF TRA JOH COVIDIEN 120100045X

    Patients

    Seq Age Sex Outcome Treatment
    1