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

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Cough (4457)

Event Date 10/10/2019

Event Type  Injury  

Event Description

I started getting a cough and dry nose and throat after starting cpap therapy at night.There were black particles in the exhalation filter on the cpap mask.Fda safety report id# (b)(4).

• Brand Name: PHILIPS RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 13514465
• MDR Text Key: 285550505
• Report Number: MW5107397
• Device Sequence Number: 1
• Product Code: BZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 101 KG