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

Device Problems Unexpected Therapeutic Results (1631); Patient Device Interaction Problem (4001)

Patient Problem Chest Pain (1776)

Event Date 10/18/2021

Event Type  Injury  

Event Description

I have been using my dreamstation philips cpap machine for about a year now.One thing i noticed is that when i do not use it, (for instance when i fall asleep for a quick nap).When i wake up my upper chest hurts and feels strained.Before i started the cpap machine, i didn't have this kind of pain in my chest after sleeping.I feel like the machine is making my sleep apnea worse, and when i don't have my machine available or fall asleep on accident, it's a lot worse than it was before starting the therapy.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12672507
• MDR Text Key: 278084577
• Report Number: MW5104814
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/18/2021

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Weight: 88