BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS RESPIRONICS DREAMSTATION AUTO CPAP

    MDR report key: 12075087 · Received June 25, 2021

    Report

    Report Number
    MW5102159
    Event Type
    Injury
    Date Received
    June 25, 2021
    Report Date
    June 23, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ND, US
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED TO EXPERIENCE CHEST TIGHTNESS, CHEST PAIN FOR DUE TO INFLAMMATION FELT TO BE CAUSED BY HER PHILLIPS RESPIRONICS DREAMSTATION AUTO CPAP, WHICH HAS RECENTLY BEEN RECALLED. SHE WENT TO ED FOR CHEST PAIN ON (B)(6) 2021 FOR CHEST PAIN, NO CARDIAC CAUSE FOUND. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961303 PHILLIPS RESPIRONICS DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1