MAUDE Adverse Event Report: PHILIPS ELECTRONICS LTD SYSTEM ONE; VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING

Patient Problems Atrial Fibrillation (1729); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Cough (4457); Renal Impairment (4499)

Event Type  Injury  

Event Description

Began using philips cpap in 2010.Shortly after, began coughing, shortness of breath and sinus issues.Developed a-fib(atrial fibrillation), heart failure, and chronic kidney disease.

• Brand Name: SYSTEM ONE
• Type of Device: VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
• Manufacturer (Section D): PHILIPS ELECTRONICS LTD
• MDR Report Key: 18596395
• MDR Text Key: 334088746
• Report Number: MW5150836
• 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: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Other; Hospitalization; Disability
• Patient Age: 75 YR
• Patient Sex: Male