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

Model Number DSX200H11

Patient Problems Asthma (1726); Chest Pain (1776); Dyspnea (1816); Headache (1880); Rash (2033); Blurred Vision (2137); Unspecified Heart Problem (4454)

Event Type  Injury  

Event Description

Began using philips dreamstation cpap (continuous positive airway pressure) in 2018.Suffers from asthma, rashes, shortness of breath, migraines, blurry vision, chest pain and heart palpitations since using the machine.Diagnosed with a-fib (atrial fibrillation) in late 2018.

• Brand Name: DREAMSTATION
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS/RESPIRONICS, INC.
• MDR Report Key: 18151118
• MDR Text Key: 328525981
• Report Number: MW5148205
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DSX200H11
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN.
• Patient Outcome(s): Disability; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American