BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIP'S RESPIRONICS DREAMSTATION

    MDR report key: 12703883 · Received October 26, 2021

    Report

    Report Number
    MW5104963
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    November 17, 2018
    Report Date
    October 22, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    USED PHILIP'S DREAMWEAVER CPAP/BIPAP AND NOW AM INCAPACITATED WITH IPF, A LIVER AND AN EYE PROBLEM. DISCOVERED BOGUS LEGAL WEBSITES BUT WOULD LIKE TO JOIN A CLASS ACTION SUIT. I WAS IN (B)(6) WHEN ILLNESS OCCURRED AND I NOW LIVE IN (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598726 PHILIP'S RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500H11

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| O| S