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

Device Problems Nonstandard Device (1420); Particulates (1451); Product Quality Problem (1506); Noise, Audible (3273)

Patient Problems Aspiration/Inhalation (1725); Cough (4457)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

My philips dream station was on the recall list and the replacement unit was received 10/24/22.The unit replacement did not appear to be in as good of condition as the one it was replacing however, i went ahead and set it up according to their directions.On (b)(6) "2022" was the first night using the replacement device and i feel as though i was breathing in particles, unlike anything i have ever experienced with my original device.The expected particles gave me a cough that evening, and i noticed that the machine had a noise that my original machine does not have.Second night usage, the noise was pronounced and kept me awake until i decided to stop using the replacement.I did reach out to philips this morning, they said your agency is aware of their replacements being refurbished units.However, i asked if you were aware of philips replacing these units with products with units that are not equivalent to what a person purchased.I have 3 years before my insurance will pay for another cpap, and this replacement is already unsatisfactory.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAM STATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 15699199
• MDR Text Key: 302807365
• Report Number: MW5112961
• 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: 10/27/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2022
• Patient Sequence Number: 1
• Treatment: FOSTEUM PLUS, LEVOTHYROXINE, PANTOPRAZOLE, OLMESARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, METFORMIN, FARXIGA, VASCEPA, ATORVASTATIN, TOVIAZ, MOUNJARO.
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic