MAUDE Adverse Event Report: PHILIPS/RESPIRONICS, INC. PHILIPS RESPIRONICS DREAMSTATION 2 AUTO CPAP ADVANCED; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION 2

Device Problems Contamination (1120); Nonstandard Device (1420); Particulates (1451); Pressure Problem (3012)

Patient Problem Cough (4457)

Event Date 05/26/2023

Event Type  malfunction  

Event Description

This is regarding the dreamstation 2 cpap (continuous positive airway pressure) machine that philips respironics sent me to replace my recalled philips system one cpap (continuous positive airway pressure) machine.I used it for the first time on (b)(6) 2023.I used it for one hour on the first night but had to stop because the delivery pressure was inadequate.I used it for about four hours each on the second and third night but had to stop because the delivery pressure was still inadequate.On the night of (b)(6) 2023, upon starting use of the cpap (continuous positive airway pressure), i immediately started coughing.I turned the cpap (continuous positive airway pressure) off, removed the cpap (continuous positive airway pressure) mask, and opened up the humidifier reservoir in order to check the water level.When doing so i noticed a lot of white fibrous debris floating in the water in the reservoir.I did not use the machine after seeing that.I recorded some video of the debris floating in the humidifier water.The next day i washed the reservoir tank, mask, and tubing with soap and water.I then re-connected everything to the cpap (continuous positive airway pressure) machine and refilled the reservoir tank with new distilled water.I then ran the cpap (continuous positive airway pressure) for just a minute without putting the mask on.After that, i checked the reservoir and again there was white fibrous debris floating in the water.Again i recorded a video.I am extremely concerned about the fibrous debris that i breathed in over the four night period from (b)(6) 2023 through (b)(6) 2023 and the potential for long term health consequences or health problems in the near future.Just as a reminder, this is not the unit that was recalled.This is the unit that philips sent me to replace the unit that was recalled.I no longer trust philips respironics to provide a safe product.I have several videos of the debris floating in the cpap (continuous positive airway pressure) humidifier reservoir tank which are much more clear and definitive.If you are interested in seeing them please let me know if there is a way to upload them and send them to you (they are larger files).The pictures i have attached also show the white fibrous debris but they are not as clear.Thank you.Reference report: mw5118510.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 17182479
• MDR Text Key: 317791564
• Report Number: MW5118509
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION 2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White