BEUDAMED
    FDA Adverse Event Summary report: N

    PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES

    MDR report key: 4241402 · Received November 10, 2014

    Report

    Report Number
    1531186-2014-05502
    Date Received
    November 10, 2014
    Report Date
    October 22, 2014
    Manufacturer
    RESPIRONICS INC
    Product Code
    BTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES THE UNIT HAS LOW OUTPUT, IT TAKES TOO LONG TO RECEIVE TREATMENT. CUSTOMER STATES THE UNIT IS MAKING NOISE AFTER RUNNING FOR AWHILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722152 PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES 868.6250 BTI RESPIRONICS INC IRC1710

    Patients

    Seq Age Sex Outcome Treatment
    1 Other