MAUDE Adverse Event Report: PHILIPS RESPIRONICS / RESPIRONICS, INC. PHILIPS RESPIRONICS DREAMSTATION2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number DREAMSTATION2

Device Problems Nonstandard Device (1420); Defective Device (2588)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/23/2023

Event Type  Injury  

Event Description

I had to return my cpap device as part of the philips respironics recall.Many, many months after the recall was announced, i finally received a replacement device.The replacement device is not working to control my sleep apnea and as a result, i have suffered from medical side effects.I have had to resort to using my travel cpap device which is not intended for daily use and is causing issues health-wise.I have contacted the company on multiple occasions asking for a replacement, refund or for them to return my old device.Their suggestion has been for me to make an appointment with my doctor and have my doctor look at the defective product, at my cost.This is not an acceptable solution, i am not going to pay for a doctor visit to have them confirm the product i received is defective.The last 2 times i called them, i asked to be transferred to a supervisor and was hung up on twice.They won't even respond to my emails anymore.I have monetarily and physically been injured by the recall and their response to it.I need resolution from them and cannot get it.

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS / RESPIRONICS, INC.
• MDR Report Key: 16887521
• MDR Text Key: 314836022
• Report Number: MW5117325
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DREAMSTATION2
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White