BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILLIPS DREAMSTATION

    MDR report key: 12136442 · Received July 7, 2021

    Report

    Report Number
    MW5102359
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    May 15, 2021
    Report Date
    July 3, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I NOTICED BLACK SPECKS FLOATING IN MY WATER TANK OF MY DREAMSTATION MACHINE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029635 PHILLIPS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR