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

Device Problem Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

I have a philips dreamstation and have black particles in the water compartment.My therapist has given me a filter to put on the tubing for now but i'm concerned about its safety.This is a correction of a serial number on a report i just submitted within the last hour.I apologize for the confusion.Fda safety report ids# (b)(4).

• Brand Name: DREAMSTATION CPAP MACHINE
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13170098
• MDR Text Key: 283337207
• Report Number: MW5106474
• 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: 01/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female