MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. DREAMSTATION BIPAP S/T; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Model Number DREAMST ST30 H/C DS

Device Problem Nonstandard Device (1420)

Patient Problems Headache (1880); Cough (4457); Unspecified Respiratory Problem (4464)

Event Date 10/18/2022

Event Type  Injury  

Event Description

Started and continue to have respiratory issues, coughing, and sinus headache which may be related to the use of a recalled philips respironics bpap.I have seen different doctors and i requested a replacement 1.5 years ago and still waiting for that replacement.

• Brand Name: DREAMSTATION BIPAP S/T
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 17192285
• MDR Text Key: 317865835
• Report Number: MW5118732
• Device Sequence Number: 1
• Product Code: MNS
• 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: 06/19/2023

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: DREAMST ST30 H/C DS
• Device Catalogue Number: DSX1030H11C
• Device Lot Number: 30H11CSNJ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Patient Sequence Number: 1
• Treatment: AVALIDE; IBUPROFEN; METHOTREXATE; NEXIUM; NUVIGIL
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White