BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NON-REBREATHING MASK W/O SAFETY VENT

    MDR report key: 3008628 · Received March 13, 2013

    Report

    Report Number
    3004365956-2013-00067
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 25, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION TEST WAS PERFORMED ON A PICTURE PROVIDED BY THE CUSTOMER, HOWEVER THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE SAMPLE DEVICE IS NECESSARY TO EVALUATE FOR FUNCTIONAL ISSUES. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED. CUSTOMER COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE INVOLVED IN THIS ISSUE WAS NOT PROVIDED FOR EVAL. ROOT CAUSE CANNOT BE ESTABLISHED. TELEFLEX WILL CONTINUE TO MONITOR VIA PERIODIC REVIEWS TO EVALUATE IF ANY TRENDS EXIST.

    Description of Event or Problem · 1

    THE COMPLAINT REPORTED AS: THE RESERVOIR OF THE MASK DID NOT INFLATE WITH THE FLOW RATE OF 12L/M. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104886 HUDSON NON-REBREATHING MASK W/O SAFETY VENT NON-REBREATHING MASK BYG TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1