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

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Inflammation (1932); Respiratory Tract Infection (2420); Cough (4457)

Event Date 06/01/2018

Event Type  Injury  

Event Description

Increased breathing issues; while using the dreamstation cpap device i had increased cough, upper respiratory infection, and sinus infections forcing me to change masks multiple times and i ultimately had to return the cpap to the "areocare" provider because i could not use any longer with such complications.I was labeled non compliant by medicaid because i wasn't able to use it (i was dx in 2018 wore it 3 months and returned it).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: 12697069
• MDR Text Key: 278559326
• Report Number: MW5104933
• 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: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 104