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

Device Problems Nonstandard Device (1420); Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 05/01/2022

Event Type  malfunction  

Event Description

Use philips respironics dream station 2 cpap machine.I continue to find small dark pieces of some kind of material in my hose each week when i clean it and have been finding them for months.Today, (b)(6) 2022, i received a recall notice from philips for several models of their ventilator machines.Their website says my model is not included in the recall.I'm wondering why since my machine seems to be having the same problem as the recalled machine.Seems to me your department should look into this model as well.Fda safety report id# (b)(4).

• Brand Name: DREAM STATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 14593360
• MDR Text Key: 293441487
• Report Number: MW5110085
• 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: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1