BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS DREAM STATION CPAP

    MDR report key: 12210754 · Received July 21, 2021

    Report

    Report Number
    MW5102698
    Event Type
    Injury
    Date Received
    July 21, 2021
    Report Date
    July 15, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RECURRENT SINUS INFECTIONS; RECURRENT SINUS INFECTIONS. USE PHILLIPS DREAM STATION CPAP THAT HAS BEEN RECALLED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104804 PHILLIPS DREAM STATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DREAMSTNAUTOCPAPHUMCELL DOM

    Patients

    Seq Age Sex Outcome Treatment
    1 Other