BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS DREAM STATION GO CPAP

    MDR report key: 18040470 · Received October 30, 2023

    Report

    Report Number
    MW5147519
    Event Type
    Injury
    Date Received
    October 30, 2023
    Report Date
    October 25, 2023
    Manufacturer
    PHILIPS / RESPIRONICS INC.
    Product Code
    MNS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SINCE USING A PHILIPS DREAMSTATION GO, I DEVELOPED REPEATED ATTACKS OF PLEURISY WITH OTHER SYMPTOM DIAGNOSED AS SJOGREN'S SYNDROME. THESE SYMPTOMS INCLUDE DRY EYES, DRY MOUTH, FEVER, MIGRATORY ARTHRALGIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100843 PHILIPS DREAM STATION GO CPAP VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS PHILIPS / RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R| S IVIG 20 GM EVEY TWO WEEKS| ASPIRIN 81 MG 1 EVERY OTHER DAY | BIOTIN 500 MCG/DAY| BYSTOLIC 5 MG 1/DAY | COLCHICINE 0.6 1 PER DAY | ESTRADIOL .01 PER VAGINA TWICE PER WEEK | FOSAMAX 70 MG 1 PER WEEK| HYDROXYCHLOROQUIN 200 PER DAY | LOSARTAN 50 MG 1 PER DAY | METHOTREXATE 2.5 MG 6/QWK | MULTIVIT ZINC 1 PER WEEK | PREDNISONE 5 MG/DAY | RESTASIS 1 DROP EACH EYE TWICE PER DAY | RITUXAN IV EVEY 4 MONTHS| SYSTANE EYE DROPS FOLIC ACID 2 PER DAY | VITAMIN D3 5000 U / DAY