BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS CPAP

    MDR report key: 14632565 · Received June 7, 2022

    Report

    Report Number
    MW5110180
    Event Type
    Injury
    Date Received
    June 7, 2022
    Date of Event
    June 10, 2021
    Report Date
    June 3, 2022
    Manufacturer
    PHILIPS OR RESPIRONICS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVELOPED ADVANCED COPD; I WAS NEVER NOTIFIED BY THE MANUFACTURER, DISTRIBUTOR OR MY SLEEP DOCTOR OF THE RECALL. I STARTED COUGHING WHEEZING, SHORTNESS OF BREATH AND HAD DIFFICULTY IN BREATHING. I CALLED MY PRIMARY DOCTOR AND HE SENT ME FOR TESTS AND PRESCRIBED MEDICATION TO RELIEVE THE PROBLEM. I WAS PERFECTLY NORMAL AND HEALTHY PRIOR TO THIS INCIDENT. I NOW HAVE COPD AND I AM ANGRY AND UPSET. I NOW HAVE TO US A NEBULIZER FOUR TIMES A DAY, WHICH IS NOT 100% EFFECTIVE IN RELIEVING MY DISCOMFORT. MY LIFESTYLE HAS CHANGED CONSIDERABLY. WITH NO FAULT OF MINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324726 PHILIPS CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS OR RESPIRONICS / RESPIRONICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Other BLOOD PRESSURE PILL| VIT D