BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS RESPIRONICS DREAMSTATION

    MDR report key: 12276090 · Received August 3, 2021

    Report

    Report Number
    MW5102983
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    October 1, 2020
    Report Date
    August 1, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHITE COATING NOTED IN THE MASK OF MY PHILLIPS RESPIRONICS DREAMSTATION CPAP( SERIAL NUMBER: (B)(4)). THE COATING STUCK TO THEN INSIDE OF THE MASK AND I NEEDED TO SCRUB IT OFF. I HAVE ONLY USED (B)(6) BABY SHAMPOO, AS INSTRUCTED BY (B)(6) HEALTHCARE, TO CLEAN THE MASK AND TUBING. I DID DEVELOP A RED RASH ON MY CHEEKS AFTER THIS OCCURRED. I DON'T KNOW IF I WILL HAVE ANY LASTING OR DELAYED EFFECTS FROM MY EXPOSURE TO THE BURNING/MELTING POLYURETHANE IN MY EQUIPMENT. THIS IS PART OF THE ONGOING NATIONWIDE RECALL. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166327 PHILLIPS RESPIRONICS DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability