MAUDE Adverse Event Report: PHILIPS RESPIRONICS, INC. DREAM STATION AUTOCPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

I have been diagnosed, after a sleep study done by my pulmonologist in (b)(6), with sleep apnea and have been prescribed a cpap since (b)(6) 2019.My unit stopped working in (b)(6) 2023.It stopped delivering the programmed amount of air and just started blowing a very low flow of air.I learned through my new pulmonology p.A in (b)(6) in late april (it took that long to get an appt.With them that philips respironics had a recall.They told me to register my device with philips respironics which i did that week.I received a replacement dream station cpap/auto pap machine from philips respironics as a result of their foam/insulation recall.It did not work properly and only delivered a very low airflow regardless of the programmed setting.This also occurred while using the auto pap mode.Same problem that i encountered with my original unit after approx.3 yrs of use.I reported this problem via their 1-833-262- 1871 and 877-907-7508 customer service depts.A second replacement cpap machine was sent to me in mid (b)(6) 2023.It also didn't work and delivered the exact low pressure that my previous replacement device delivered.This low air flow occurred both in auto and programable cpap mode.When i called to report this issue on "(b)(6)" i was initially told by a customer service rep via a phone that i would be contacted by the "back end" team to receive another replacement unit.When i followed up today ((b)(6)) and spoke with (b)(4) i was told that there is no record of that discussion and they could not send me a replacement dream station device without me seeing my pulmonologist again.I believe based on my experiences that philips respironics has a much larger problem than they are acknowledging or reporting to the fda.Reference reports: mw5118781.

• Brand Name: DREAM STATION AUTOCPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS, INC.
• MDR Report Key: 17199532
• MDR Text Key: 317949974
• Report Number: MW5118780
• 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: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White