MAUDE Adverse Event Report: PHILIPS / RESPIRONIC, INC. SYSTEMONE CONTINUOUS POSITIVE AIRWAY PRESSURE C-FLEX; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Patient Problem Renal Failure (2041)

Event Date 03/11/2021

Event Type  Injury  

Event Description

Began using philips continuous positive airway pressure in 2014.Diagnosed with end stage renal disease on (b)(6) 2021.

• Brand Name: SYSTEMONE CONTINUOUS POSITIVE AIRWAY PRESSURE C-FLEX
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS / RESPIRONIC, INC.
• MDR Report Key: 18589731
• MDR Text Key: 333957642
• Report Number: MW5150785
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• 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): Required Intervention; Other; Hospitalization; Disability; Life Threatening
• Patient Age: 52 YR
• Patient Sex: Male