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

Device Problems Material Separation (1562); Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Nasal Obstruction (2466)

Event Type  Injury  

Event Description

Sinus infections; carcinogenic foam breaking off the philips cpap and lodging in sinuses.Forced to cease using.Fda safety report id # (b)(4).

• Brand Name: RESPIRONICS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 13472757
• MDR Text Key: 285360590
• Report Number: MW5107247
• 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: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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
• Treatment: ASPIRIN; ATORVASTATIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic