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

Device Problems Material Fragmentation (1261); Nonstandard Device (1420)

Patient Problems Pulmonary Emphysema (1832); Cancer Cells Dissemination (4541)

Event Type  malfunction  

Event Description

This information is being presented to the fda because i don't believe philips respironics has reported the complete set of problems with the foam contamination in their cpap and other machines.I believe there are likely others besides the users who are being exposed to the particles and carcinogenic gases by the air output of the machines.I have been using these respironic machines for 15 years, 2 system ones and 1 dreamstation, all 3 of these units have been recalled by philips.Within the last 2 years my wife and i have both been diagnosed with emphysema.Earlier this year my wife had rotocuff surgery and during the pre op pet scan they found that she had lung cancer, an adenocarcinoma which required lung surgery to remove a section of her upper right lung lobe.She now has stage one lung cancer.When i received the notification from philips about the recall and the details of the contaminants, i thought of my wife having been in very close quarters with me in bed for so many years being subjected to the exhaust air from my mask and there by also getting the same carcinogenic gases and particles that i got.These recalled machines are called cpap machines because they supply a continuous pressure of air to hold open collapsed airways, the user's respiration takes place inside the air pocket created by the air pump in the machine and that air must be exhausted through the mask in order to maintain that continuous pressure.It is like having 2 different air systems with 1 operating inside the other which leads me to believe the user would not receive nearly as much air from the machine during the breathing cycle as a person exposed to the exhaust from the mask which is continuous.As long as the machine is turned on it supplies the air at it's set pressure continuously.I believe that with in an 8 hour sleeping period these machines could pump a very large amount of contaminates into the environment of a bedroom and affect every breathing person in that room.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION BY PHILIPS RESPIRONICS
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13025759
• MDR Text Key: 282704637
• Report Number: MW5106128
• 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: 12/14/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1