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

Patient Problem Discomfort (2330)

Event Date 06/01/2023

Event Type  Injury  

Event Description

I have had 3 cpap maxine's from philips.The first one was recalled.Months later i received the dream station 2.It over heated.The water was causing it to smell.Called philips and reported it.They put me through many tests of this machine.After several phone calls they finally agreed to send me a replacement.I received the next machine and this one is also overheating or not working at all.This could be a dangerous hazard.I turned off all the settings which is very uncomfortable.Humidifier is off which and heated tubing is not working.This needs to be reported.This is ineffective and dangerous products.This needs to be stopped.Reference report #mw5150400, #mw5150402.

• Brand Name: PHILIPS DREAM STATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILPS / RESPIRONICS, INC.
• MDR Report Key: 18526601
• MDR Text Key: 333223456
• Report Number: MW5150401
• 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: 01/11/2024

1 Device was Involved in the Event

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: 01/16/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White