BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILIPS DREAM STATION 2 AUTO CPAP ADVANCED

    MDR report key: 13111694 · Received December 28, 2021

    Report

    Report Number
    MW5106338
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    May 1, 2021
    Report Date
    December 24, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE BEEN USING A RECALLED PHILIPS CPAP MACHINE FOR 9 MONTHS. I HAVE HAD A DRY COUGH, LUNG IRRITATION AND DISCOMFORT WHEN TAKING A DEEP BREATH SINCE I GOT THE MACHINE BUT DID NOT CONNECT THE DOTS. I ALSO HAVE KIDNEY PAIN IN THE MORNING. THIS MAY OR MAY NOT BE RELATED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000146 PHILIPS DREAM STATION 2 AUTO CPAP ADVANCED VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female LAMOTRIGINE 200 MG| LISINOPRIL 20 MG| METFORMIN 2000 MG