BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS / RESPIRONICS, INC.

    MDR report key: 12348489 · Received August 19, 2021

    Report

    Report Number
    MW5103376
    Event Type
    Injury
    Date Received
    August 19, 2021
    Date of Event
    January 1, 2019
    Report Date
    August 10, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FROM (B)(6) 2019 I HAD SEVERE S.O.B., REQUIRING INHALERS, NEBULIZERS AND MULTIPLE MEDS INCLUDING ABXS AND STEROIDS. I HAD SEVERE LETHARGY, SKIN IRRITATION, SORE THROAT, AND HEAT IN MY FACE. I DISCOVERED THAT THERE IS A RECALL ON MY CPAP MACHINE. I USED CPAP MACHINE - THE DREAM STATION FROM PHILIPS RESPIRONICS FOR MORE THAN 5 YEARS. ON (B)(6) 2021, I STOPPED THE USE OF THE CPAP MACHINE WITH SIGNIFICANT IMPROVEMENT IN MY HEALTH IN THIS LAST WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237758 PHILIPS / RESPIRONICS, INC. VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500H11

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR