BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILLIPS RESPIRONICS CPAP

    MDR report key: 12143077 · Received July 8, 2021

    Report

    Report Number
    MW5102417
    Event Type
    Malfunction
    Date Received
    July 8, 2021
    Date of Event
    May 15, 2018
    Report Date
    July 7, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED A PHILLIPS CPAP DEVICE SINCE 2014. STARTING A FEW YEARS AGO, NOTICED JUST AFTER WAKING UP FROM A NIGHT'S SLEEP FROM USING THE CPAP, I WOULD COUGH UP A LIGHT ALMOST GRITTY (MICRO-GRIT) PHLEGM ON A LOT OF OCCASIONS. THIS WOULD LAST THROUGHOUT THE DAY. THEY BECAME LESS FREQUENT OVER TIME BUT DEFINITELY CONTINUED TO OCCUR. I'VE RECENTLY STOPPED USING THE CPAP AND SINCE I HAVE, I'VE NEVER HAD INCIDENCES OF COUGHING UP GRITTY PHLEGM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035019 PHILLIPS RESPIRONICS CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC. P11836409EB8D

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other