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

Model Number AUTOCPAPHUMHTDOM

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Fatigue (1849); Cognitive Changes (2551)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Unsure of exact date, but chronic fatigue and foggy brain worsened during past year or two impacting my work.I was confused because cpap should help.Also coughing.Fda safety report id # (b)(4).

• Brand Name: PHILIPS DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/ RESPIRONICS, INC.
• MDR Report Key: 14522053
• MDR Text Key: 292976214
• Report Number: MW5109956
• 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: 05/24/2022

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 Operator: Lay User/Patient
• Device Model Number: AUTOCPAPHUMHTDOM
• Device Lot Number: DSX500T11
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White