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

Model Number DSX520T11C

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Fatigue (1849); Tachycardia (2095); Sore Throat (2396); Low Oxygen Saturation (2477); Cognitive Changes (2551); Chemical Exposure (2570); Dry Mouth (4485)

Event Date 01/04/2024

Event Type  Injury  

Event Description

I started cpap therapy in 2021 and for 8 months used the philips dreamstation until it was recalled.I received a replacement philips dreamstation2.From 2021 until (b)(6) 2024 my health declined and my doctors said it was chronic fatigue syndrome as no other diagnosis could be found.I had pronounced fatigue, and muscle fatigue, and brain fog.Starting in (b)(6) 2023 i started having heavy chest feeling and throat/airway irritation.In (b)(6) 2024 i woke up smelling electrical smoke in my cpap mask.I don't know how long i was breathing this.I turned off the humidifier for about a week, but was getting throat irritation from dryness, so i turned it back on.After another week or ten days i again woke up smelling electrical smoke in my cpap mask.During this time my fatigue and muscle fatigue became much worse and my 02 levels ranged between 92 and 96.My heart would race if i did any small task, like walking from my chair to the bathroom and my breathing by the end of the day was very labored.I asked my doctor and my pulmonologist and my pulmonologist schedule an echocardiogram for me.Then my wife said she read an fda warning about philips dreamstation 2 machines online.My doctor assumed my cfs was getting worse.I told my pulmonologist about the fda warning (they didn't know).I told my durable medical equipment company about the fda warning (they didn't know).I was afraid to use my cpap machine, but couldn't go without it because i have central and obstructive sleep apnea.I kept the humidifier off while (b)(6) and my (b)(6) company figured out how to get me a new resmed machine.I receive the resmed machine on (b)(6).After only one night using that machine i felt remarkably better.During the next 7 days my 02 levels kept gaining and are now at between 97 and 99.After two nights my muscle fatigue and racing heart were all but gone.My chest heaviness was gone but i still have throat and upper airway irritation.My pulmonologist has scheduled a ct scan to see if there has been any permanent damage.I have chemical sensitivities and come to find out, i've had all the symptoms of overexposure to formaldehyde, and i don't know what i breathed in the two times i woke up with electrical smoke in my cpap mask.I don't know why as a user of a philips machine, i wasn't informed of the issues with this machine.I'm not sure if i have any permanent damage as we are still doing tests.

• Brand Name: DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS INC.
• MDR Report Key: 19153539
• MDR Text Key: 340865306
• Report Number: MW5154055
• 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: 04/18/2024

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: DSX520T11C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Patient Sequence Number: 1
• Treatment: LORAZEPAM.; MAGNESIUM, COQ10.; RESMED 10 CPAP MACHINE.; VITAMIN B6.; VITAMIN D.
• Patient Outcome(s): Disability
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White