BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE

    MDR report key: 4240085 · Received November 4, 2014

    Report

    Report Number
    1044475-2014-00301
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 23, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT. SERIAL NUMBER OF THE DEVICE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THE MEDICATION IS NOT BEING INFUSED PROPERLY. THE TREATMENT IS TAKING TOO LONG AND THE MIST IS VERY LIGHT. THE MOTOR IS RUNNING LOUDER. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707815 HUDSON OPTI-NEB PRO COMPRESSOR W/DISPOSABLE NE NEBULIZER COMPRESSOR CAF TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1