BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS CPAP

    MDR report key: 12632614 · Received October 13, 2021

    Report

    Report Number
    MW5104585
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    May 5, 2020
    Report Date
    October 7, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I STARTED TO HAVE HEADACHE, EYE IRRITATION, UPPER AIRWAY IRRITATION, ASTHMA AND SINUS INFECTION FROM TIME TO TIME SINCE EARLY LAST YEAR. THE SYMPTOMS ARE GETTING MORE AND MORE FREQUENT AND WORSE WITH TIME. I CURRENTLY HAVE THESE SYMPTOMS ALMOST EVERYDAY NOW SINCE EARLY (B)(6). I RECEIVED A LETTER FROM PHILIPS RESPIRONICS TODAY TALKING ABOUT THE RECALL OF THE CPAP DEVICE I HAVE BEEN USING SINCE LATE 2016/EARLY 2017. ALL MY SYMPTOMS ARE EXACTLY SAME AS THE SYMPTOMS LISTED IN THE RECALL LETTER THAT IS RESULTING FROM THE ISSUES OF THE DEVICE. PE-PUR FOAM USED IN THE DEVICE MAY DEGRADE INTO PARTICLES WHICH MAY ENTER THE DEVICE'S AIR PATHWAY AND BE INGESTED OR INHALED BY THE USER AND THE PE-PUR FOAM MAY OFF-GAS CERTAIN CHEMICALS WHICH ARE HARMFUL TO THE USERS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526315 PHILIPS RESPIRONICS CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. REF DSX500T11C 2016-11-17

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R