BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP W/ HUMIDIFIER CELL

    MDR report key: 12665063 · Received October 19, 2021

    Report

    Report Number
    MW5104770
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    October 1, 2020
    Report Date
    October 15, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    COUGH; WAS PRESCRIBED PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP BY (B)(6) TO RELIEVE 70 APNEAS/HOUR EVENTS DURING SLEEP. WITHIN A MONTH WAS NOTIFIED THAT PRESSURE WOULD BE INCREASED DUE TO COLLECTED AND REPORTED DEVICE DATA. WITHIN ANOTHER MONTH EXPERIENCED TIGHTNESS IN RIGHT CHEST. I WAS REFERRED TO PULMONARY SPECIALIST BY PRIMARY CARE PHYSICIAN WHO CONFIRMED, VIA CHEST CT SCAN, THE PRESENCE OF A 4MM MASS IN MY RIGHT CHEST. AWAITING FURTHER INSTRUCTIONS BY ALL INVOLVED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559986 PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP W/ HUMIDIFIER CELL VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other