MAUDE Adverse Event Report: PHILIPS / RESPIRONICS INC. PHILIPS DREAM STATION GO CPAP; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Patient Problems Dry Eye(s) (1814); Fever (1858); Arthralgia (2355); Pleural Empyema (4459); Dry Mouth (4485)

Event Type  Injury  

Event Description

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.

• Brand Name: PHILIPS DREAM STATION GO CPAP
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18040470
• MDR Text Key: 327131237
• Report Number: MW5147519
• Device Sequence Number: 1
• Product Code: MNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2023
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White