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

Model Number DSX500S11

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2021

Event Type  Injury  

Event Description

I noticed that there was an accumulation of a black powder in and around the filter port of my dreamstation cpap.This has been getting progressively worse over the past weeks.When i showed this to my provider i was informed that i needed to make an appointment with my sleep specialist.He cannot see me till mid-december.I am expected to continue to use the machine in its current condition till that time.I fear for my health under these conditions for that length of time but i have no concerned advocate for my cause in my area.Fda safety report id# (b)(4).

• Brand Name: DREAMSTATION CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12719424
• MDR Text Key: 279273123
• Report Number: MW5105017
• Device Sequence Number: 1
• Product Code: BZD
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX500S11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 113