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

Model Number DSX520H11C

Patient Problems Aspiration/Inhalation (1725); Sore Throat (2396); Cough (4457)

Event Date 12/10/2023

Event Type  Injury  

Event Description

I am a pulmonary and critical care physician - using my personal philips respironics dream station 2 cpap machine.This was a replacement sent to me directly, with no intermediary, by philips after waiting almost a year (or longer) for my replacement of their dream station 1 for recall of the sound abatement foam.I was sleeping and my alarm went off at 5:20 am pst to go to the hospital, i noticed a smell through my mask that smelled like burned wax, i looked over and there is a column of smoke rising from my cpap machine.I immediately turned it off and unplugged it.I didn't see any open flame.I have been coughing with a scratchy throat for the last hour since i have awakened.I have no idea if the smoke is toxic as a by product of something burning in the machine, or how much smoke inhalation i had.Philips needs to be held to account for creating faulty equipment not once but twice, for a life saving device (over the long run).I could have been (possibly could be we will see) seriously injured by what occurred, and this needs to be resolved and the company held to account.It is dangerous.My wife also saw the smoke rising from the machine and can also file a report if needed.Ref report: mw5149224.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18324741
• MDR Text Key: 330855248
• Report Number: MW5149223
• 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: 12/10/2023

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
• Device Model Number: DSX520H11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White