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

Model Number ORIGINAL DREAMSTATION

Device Problem Particulates (1451)

Patient Problems Aspiration/Inhalation (1725); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 07/01/2021

Event Type  Injury  

Event Description

I have a heavy chronic cough that developed around (b)(6) 2021 and has developed into sinus issues and having the need to clear throat and spit out mucus or snot.I noticed in (b)(6) 2022 that when spitting or clearing of throat i had black specs in mucus every time i had a fairly deep cough.I am still spitting out said black particles.I have had 3 separate sputum tests but even though you can visibly see the particles in the mucus/samples they cant determine what it is.The last of the 3 was an actual particulate test/apparently.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION AUTO CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 15879104
• MDR Text Key: 304517658
• Report Number: MW5113513
• 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: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: ORIGINAL DREAMSTATION
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White