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

Model Number DSX520T11C

Patient Problem Aspiration/Inhalation (1725)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

Woke up with soot in my nose, use a nasal mask, philips dream station 2, cpap machine a replacement in 2021 for a recall, looked at the filters both disposable and non-disposable and the following picture is what i found.Refer to add'l documents in i2k.

• Brand Name: PHILIPS DREAMSTATION 2 CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS INC.
• MDR Report Key: 18667922
• MDR Text Key: 335071672
• Report Number: MW5151177
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX520T11C
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ARTOVASTATIN 10MG ; CPAP; IRBESARTAN 150MG ; VITAMIN D3 1000MG
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White