BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP HUMID/HT DOM

    MDR report key: 8069558 · Received November 13, 2018

    Report

    Report Number
    MW5081210
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    November 3, 2018
    Report Date
    November 6, 2018
    Manufacturer
    PHILIPS HEALTHCARE / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING A PHILIPS RESPIRONICS DREAMSTATION AUTO CPAP (REF DSX500T11, S/N (B)(4)). I AWOKE ON (B)(6) 2018 WITH RESPIRATORY DISTRESS. MY NASAL, THROAT AND LUNGS WERE BURNING. I HAD THE TASTE / SMELL OF ELECTRICAL BURNING IN MY NOSE AND THROAT. I WAS TAKEN TO THE HOSPITAL EMERGENCY ROOM AND TREATED FOR RESPIRATORY DISTRESS. I CONTACTED PHILIPS RESPIRONICS AND REPORT THE EVENT. THE COMPLAINT NUMBER IS (B)(4). I WAS INSTRUCTED BY PHILIPS RESPIRONICS TO SEND THE UNIT BACK TO THEM VIA THE SUPPLIER, (B)(4), FOR EVALUATION. I TOOK THE UNIT TO (B)(4) ON 11/05/2018, 16:00 HRS. (B)(4) WAS INSTRUCTED TO RETURN THE UNIT TO PHILIPS RESPIRONICS REFERENCING THE COMPLAINT NUMBER GIVEN BY PHILIPS. I AM SCHEDULING FOR A F/U EXAMINATION BY A PULMONOLOGIST TO EVALUATE THE EXTENT OF INJURY FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902647 DREAMSTATION AUTO CPAP HUMID/HT DOM VENTILATOR NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS HEALTHCARE / RESPIRONICS, INC. DSX500T11

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization