BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS DREAMSTATION

    MDR report key: 12861646 · Received November 22, 2021

    Report

    Report Number
    MW5105523
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    November 18, 2021
    Report Date
    November 19, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM FINDING BLACK PARTICLES AND RESIDUE IN MY MASK AND AROUND THE WATER TANK. I AM VERY CONCERNED THAT I AM BREATHING IN THESE PARTICLES DURING THE CPAP THERAPY USING THE RECALLED PHILLIPS RESPIRONICS DREAMSTATION MACHINE. I AM RECEIVING NO INFORMATION FROM PHILIPS RESPIRONICS ON THE STATUS OF MY MACHINE EVEN THOUGH I HAVE BEEN REGISTERED WITH THEM SINCE (B)(6) 2021. MY PHILIPS CONFIRMATION NUMBER FOR THIS RECALL IS (B)(4). PLEASE LET ME KNOW WHAT PHILIPS RESPIRONICS EXPECTS ME TO DO NOW THAT I AM SEEING THESE BLACK PARTICLES IN THE AIRPATH OF MY MACHINE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755801 PHILIPS RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DREAMSTATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other (B)(6)| AMLODIPINE BESYLATE, 5 MG, 1X (AM) | METOPROLOL SUCC ER, 25 MG, 1X (PM) | ROSUVASTATIN (CRESTOR), 5 MG, 1X (PM)