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

Device Problem Particulates (1451)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

I have black particles in my nose pillow filter.I cannot be without it or i stop breathing 6 times per minute.You said to stop using it immediately."what is the issue with the," help me please.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS Q SERIES
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13333710
• MDR Text Key: 284447966
• Report Number: MW5106881
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White