BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MACHINE DREAMSTATION

    MDR report key: 12075006 · Received June 25, 2021

    Report

    Report Number
    MW5102154
    Event Type
    Injury
    Date Received
    June 25, 2021
    Date of Event
    May 15, 2021
    Report Date
    June 23, 2021
    Manufacturer
    PHILIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LONG LASTING HEADACHES, EYE IRRITATION, MILD CHEST PAIN, IMBALANCE, DIZZINESS; HEADACHES LASTING FOR 35 MINUTES ON TOP OF HEAD, SLEPT WELL PREVIOUS NIGHT BUT WAS VERY TIRED FROM NOON TILL 5 PM, FELT UNSTEADY. FELL AGAINST WALLS AT HOME, DIZZINESS. WENT TO PERFORMANCE PHYSICAL THERAPY FOR VERTIGO TREATMENT. AFTER 5-6 PT SESSIONS VERTIGO PROBLEM RESOLVED. STARTING ABOUT (B)(6) 2021, HEADACHES LASTING LONGER-MORE INTENSE CONTINUOUS ALL DAY. I HAVE AN APPOINTMENT AT (B)(6) 2021. MANUFACTURED DATE 11/24/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961298 CPAP MACHINE DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS INC. DREAMSTATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| S