BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12202681 · Received July 20, 2021

    Report

    Report Number
    MW5102648
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    March 1, 2021
    Report Date
    July 16, 2021
    Manufacturer
    PHILLIPS RESPIRONICS / RESPIRONICS
    Product Code
    BZD
    UDI-DI
    00606959022485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE BEEN USING THE PHILLIPS DREAMSTATION CPAP FOR YEARS. SINCE MARCH I HAVE BEEN EXPERIENCING BLOATING, GAS, AND ESOPHAGEAL DISCOMFORT. I HAD AN UPPER GI DONE, AND GASTRITIS WAS FOUND. I HAVE NOT BEEN IMPROVING. I JUST FOUND OUT ABOUT THE RECALL, AND I AM CONCERNED THAT THE FOAM HAS BEEN HARMFUL FOR ME. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093671 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS RESPIRONICS / RESPIRONICS DSX500T11 00606959022485

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR