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

Model Number DSX400H11C

Device Problem Product Quality Problem (1506)

Patient Problems Dyspnea (1816); Headache (1880); Irritability (2421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

Event Description

From about (b)(6) 2019 to present, i started to notice a black mold-like film on my water reservoir and hose.The black substance is difficult to remove.I have experienced difficulty breathing on and off upon waking up and diagnosed with 3rd stage kidney disease.Also, i wake up with headaches almost every day with eye irritation.I own two philips cpap machines.Prior to 2019 my kidney function was above normal.Gradually kidney function has declined along with other medical issues discussed above.Fda safety report id # (b)(4).

• Brand Name: DREAMSTATION CPAP WITH HUMIDIFIER
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12554131
• MDR Text Key: 274255103
• Report Number: MW5104290
• 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: 09/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DSX400H11C
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 67 YR
• Patient Weight: 120