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

Device Problem Output Problem (3005)

Patient Problems Chest Pain (1776); Irritability (2421)

Event Date 01/07/2020

Event Type  Injury  

Event Description

I have severe sleep apnea.I was given a new philips respironics dreamstation for sleep apnea on (b)(6) 2020 and i have been using this machine since then.I had other dreamstations in the past and was given this one when there was an unsolvable technical problem with my old one.This new one, right from the start, needed to have disposable filters replaced very often.The white filters quickly became extremely dirty, unlike filters on past machines.I also noticed some lung irritation from that time, but because we were going into the pandemic and i do have some allergies, i didn't do anything about it.Recently, i had been noticing some debris in the bottom of the water reservoir after each night's use.I am rigorous in cleaning the machine - washing the headgear, nose pillows, and water reservoir every morning with dawn dishwashing detergent, the tubing every 3 days, and using only distilled water in the reservoir.I never received a recall notice from philips and only learned about the recall when i actually talked with a rep at my medical supply company today and mentioned the continual dirty filters.My check of the serial number says that my machine is affected by the recall.It is recommended that i stop use immediate because of potential toxic particles from a sound abatement foam.Since last spring, i have also had chest pain on the left, for which i have had 2 mammograms and ultrasound tests as well as physical exams of the area and an mri of the thoracic spine, which have not shown any reason for the pain i have been having since spring 2020.I don't know if this could be related, but it could be.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: 12260164
• MDR Text Key: 264718518
• Report Number: MW5102899
• 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: 07/28/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability