BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/TEE

    MDR report key: 1854137 · Received September 3, 2010

    Report

    Report Number
    3004365956-2010-00255
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 26, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR INVESTIGATION, BUT HAS NOT BEEN RECEIVED AT THIS TIME BY MANUFACTURER. A FOLLOW-UP INVESTIGATION REPORTED WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE OXYGEN TUBING ON THE NEBULIZER IS LEAKING WHEN IT IS CONNECTED. THE INCIDENT OCCURRED WHILE NEBULIZED TREATMENTS WERE BEING ADMINISTERED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUDSON NEBULIZER W/TEE NEBULIZER CAF TELEFLEX MEDICAL NA 02F10001703

    Patients

    Seq Age Sex Outcome Treatment
    1