BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 12829017 · Received November 16, 2021

    Report

    Report Number
    MW5105380
    Event Type
    Injury
    Date Received
    November 16, 2021
    Date of Event
    December 20, 2019
    Report Date
    November 13, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REGARDING PHILIPS RESPIRONICS DREAMSTATION RECALL: I STARTED USING THE MACHINE IN (B)(6) 2019. ALL LUNG TESTS PRIOR TO (B)(6) 2019 WE'RE NORMAL. MY 1ST HOSPITALIZATION WAS (B)(6) 2019 FOR ORGANIZING PNEUMONIA WITH GROUND GLASS OPACITY. SECOND HOSPITALIZATION WAS (B)(6)2020 FOR GROUND GLASS OPACITY AND INTERSTITIAL LUNG DISEASE. I'VE ALSO DEVELOPED PRIMARY BILIARY CHOLANGITIS SINCE. I HAVE CENTRAL SLEEP APNEA'S AND CAN'T AFFORD TO PURCHASE A NEW MACHINE AT (B)(6). I NEED A REPLACEMENT ASAP AND AM CONCERNED THAT THIS MACHINE CAUSED MY ILD. DIAGNOSED WITH ILD (B)(6) 2020. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716339 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention| H| S 3 INHALERS FOR LUNGS| CELLCEPT| PREDNISONE