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

Model Number DSX520T11C

Patient Problems Headache (1880); Burning Sensation (2146)

Event Date 03/14/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, 1:00 a.M., my dreamstation 2 cpap (continuous positive airway pressure) machine (philips respironics) woke me up with a very horrible smell of burning plastic.The machine felt very warm so i immediately unplugged it to prevent a fire in my bedroom.My entire bedroom was filled with this horrible smell.I had an extremely hard headache when i woke up due to the odor being inhaled into my nose and lungs.Later in the day the inside of my mouth started feeling sore with a burning sensation, particularly my tongue, roof of mouth, and gums.I have not been eating or drinking anything hot enough to burn.I am currently being treated with prescription drugs given to me by my dentist.I am also in contact with my sleep physician to acquire a new machine since i am dependent on cpap anytime i lie down.My current machine is a replacement for my previous dreamstation 1 which was recalled.I started using this current machine on (b)(6) 2022.I called philips on 3/14/24 and gave (b)(4) all the information.She said i would be getting a call back with instructions for sending them the machine.As of 3/2024 i have not received a call from them.Reference report: mw5153076.

• Brand Name: PHILIPS DREAMSTATION 2 AUTO CPAP ADVANCED
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18968847
• MDR Text Key: 338622121
• Report Number: MW5153077
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Device Catalogue Number: REV 05
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM.; GABAPENTIN FOR NEUROPATHY PAIN MEDICAL DEVICE: CPAP MACHINE.; ONE A DAY VITAMIN.; ST JOSEPH ASPIRIN.; VALSARTAN FOR BLOOD PRESSURE.; VITAMIN C.; VITAMIN D.
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White