BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 4212357 · Received October 30, 2014

    Report

    Report Number
    1531186-2014-05198
    Date Received
    October 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    RESPIRONICS INC
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT THE UNIT IS NOT WORKING AS STRONG AS IT USE TO WHEN SHE FIRST GOT IT. CONSUMER ALSO STATES WHEN SHE PUTS THE TUBING ON THE UNIT THE AIR DOES NOT REACH HER SONS NOSE OR MOUTH. CONSUMER STATES WHEN HE TAKES THE TUBING OFF OF THE UNIT SHE CAN FEEL THE AIR COMING OUT OF THE UNIT SO SHE BELIEVES IT MAY BE THE TUBING THAT NEEDS CHANGED. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694962 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI RESPIRONICS INC IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other