MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION AUTO CPAP HUMHTCELL DOM; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DSX500T11C

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 03/01/2020

Event Type  Injury  

Event Description

I began to notice shortness of breath in (b)(6) 2020.I would go for walks and would be short of breath when this had not happened before.Also, the shortness of breath would come on many times when i was sitting quietly.This has continued to the present.At the advice of my physician, i had a stress test, an echocardiogram, and saw a cardiologist twice.No definitive conclusion as to the cause was found.I stopped using the cpap device in (b)(6) 2021, to see if this improved the condition, and it did.However, my doctor had me start taking a water pill daily at the same time i stopped the cpap, so i'm not sure if that or stopping the cpap has improved the shortness of breath issue.I sometimes still get it currently, but it is not as bad as it was over the last 18 months.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP HUMHTCELL DOM
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12908624
• MDR Text Key: 281593143
• Report Number: MW5105686
• Device Sequence Number: 1
• Product Code: BZD
• 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: 11/26/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: DSX500T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2021
• Patient Sequence Number: 1
• Treatment: CALCIUM; FISH OIL ; FLAX SEED OIL ; HYDROCHLOROTHIAZIDE 25MG. DAILY; MULTIVITAMIN ; PROBIOTIC; TUMERIC
• Patient Outcome(s): Disability
• Patient Age: 75 YR
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White