BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILLIPS RESPIRONICS DREAM MACHINE

    MDR report key: 12142921 · Received July 8, 2021

    Report

    Report Number
    MW5102410
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    March 19, 2021
    Report Date
    July 6, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SEVERAL PROBLEMS: BLOODY NOSE AFTER FIRST NIGHT AND 14TH NIGHT CONTINUOUS BLOOD TINGED DISCHARGE EVERY DAY FOR FIRST MONTH OF USE. WENT TO URGENT CARE TWICE, (B)(6) I THINK FOR INFLAMED NASAL STRUCTURES AND INFECTION RASH ON FACE FROM NASAL DEVICE, LOOKED LIKE SKIN WAS BURNED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034670 PHILLIPS RESPIRONICS DREAM MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC. J30384326706E

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention