BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS DREAMSTATION CPAP

    MDR report key: 12210617 · Received July 21, 2021

    Report

    Report Number
    MW5102684
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    April 22, 2020
    Report Date
    July 15, 2021
    Manufacturer
    PHILLIPS RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I USE A PHILLIPS DREAMSTATION CPAP THAT HAS BEEN RECALLED AND INTERMITTENTLY NOTED BLACK PARTICLES IN HUMIDIFIER AND TUBING AND WAS DIAGNOSED WITH STAGE 4 METASTATIC BREAST CANCER ALONG WITH LYMPH NODES AND LEFT LUNG. USED CPAP FOR YEARS. WITH THE BREAST CANCER I HAVE HAD MULTIPLE ECHOCARDIOGRAMS, FULL BODY PET SCANS, CT SCANS, BIOPSY, CHEMO TREATMENTS, MULTIPLE IMMUNOTHERAPY TREATMENTS, AND MULTIPLE OTHER TESTS AS A RESULT. I HAVE ALSO BEEN DIAGNOSED WITH LYMPHEDEMA IN MY LEFT ARM AND HAND WITH LIFELONG TREATMENTS AND LIFELONG WEAR OF COMPRESSION GARMENTS. I CAN PROVIDE A MORE DETAILED LIST OF TESTS IF NEEDED. MULTIPLE TESTS AND CAN PROVIDE A COMPLETE LIST OF TESTS AND TREATMENTS LATER IF NEEDED. TOO MANY TO LIST HERE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104785 PHILLIPS DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S