MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPRIRONICS DREAM STATION 2; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Bacterial Infection (1735); Headache (1880); Unspecified Respiratory Problem (4464)

Event Date 10/01/2021

Event Type  Injury  

Event Description

My phillips dreamstation 1 was replaced with a philips dreamstation 2 and i am still have chronic headaches, sinus congestion, and sinus infections.Fda safety report id #:(b)(4).

• Brand Name: PHILIPS RESPRIRONICS DREAM STATION 2
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13603382
• MDR Text Key: 286369604
• Report Number: MW5107728
• 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: 02/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ATORVASTATIN ; LISINOPRIL ; METFORMIN ; VITAMIN D3; XARELTO
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White