MAUDE Adverse Event Report: PHILLIPS/RESPIRONICS INC. DREAM STATION 2 CPAP MACHINE; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Device Emits Odor (1425)

Patient Problems Aspiration/Inhalation (1725); Bronchitis (1752); Choking (2464)

Event Date 01/03/2023

Event Type  Injury  

Event Description

While using my cpap machine i woke up in the middle of the night choking and took off the face mask.I could smell a horrible burning plastic odor.I have been using this machine since (b)(6) 2021 without any problems.When i brought it to the supplier they replaced it with the same model.2 days after the incident i developed bronchitis.I was treated at an outpatient urgent care and took two weeks to recover.

• Brand Name: DREAM STATION 2 CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILLIPS/RESPIRONICS INC.
• MDR Report Key: 16254094
• MDR Text Key: 308441261
• Report Number: MW5114535
• Device Sequence Number: 2
• 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: 01/24/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: METOPROLOL, TERAZOSIN, BENAZEPRIL, ALLOPURINOL, K+, LASIX, MESALAMINE.; RED YEAST RICE, FISH OIL, MULTIVITAMIN WITH MINERALS, CALCIUM WITH VIT D, VITAMIN D, GLUCOSAMINE CHONDROITIN, B12.
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White