BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL

    MDR report key: 4956381 · Received July 31, 2015

    Report

    Report Number
    3004365956-2015-00221
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    October 23, 2014
    Report Date
    October 28, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL EXAM WAS PERFORMED AND IT WAS OBSERVED THAT THERE WAS SALINE RESIDUE ON THE MASK, JAR, JET, AND CAP. NO EVIDENCE OF KINKS, SALINE BUILD UP, OR OTHER TYPES OF OCCLUSION WERE OBSERVED IN THE TUBING OR JET. NO DEFECTS OR ANOMALIES WERE DETECTED. FUNCTIONAL TESTING WAS PERFORMED AND THE NEBULIZER MISTED PROPERLY AND THE TUBING STAYED ATTACHED DURING THE DURATION OF THE TEST. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS INCOMPLETE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DEVICE DOES NOT PRODUCE A MIST.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE DEVICE DOES NOT PRODUCE A MIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500544 HUDSON NEBULIZER W/ADULT MASK & TBG, SMALL VOL ADULT SMALL VOL. NEBULIZER CCQ TELEFLEX MEDICAL 02C1400130

    Patients

    Seq Age Sex Outcome Treatment
    1