BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL

    MDR report key: 5439048 · Received February 16, 2016

    Report

    Report Number
    3011137372-2016-00032
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 9, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCOMPLETE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED DATA: PROCODE HAS BEEN CORRECTED TO CAF. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE DEVICE IS RETURNED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE NEBULIZER DID NOT FUNCTION WITH AN OXYGEN FLOW THAT'S SUPERIOR TO 16L/MN.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE NEBULIZER DID NOT FUNCTION WITH AN OXYGEN FLOW THAT'S SUPERIOR TO 16L/MN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96872 HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL NEBULIZER, NON-VENTILATORY CCQ TELEFLEX MEDICAL 151004

    Patients

    Seq Age Sex Outcome Treatment
    1