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

Model Number SYSTEM ONE 260P C-FLEX

Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Cough (4457); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Type  Death  

Event Description

Device recall.(b)(6) had idiopathic pulmonary fibrosis and pulmonary hypertension.Defective c-pap could have made symptoms worse which caused life threatening symptoms or expedited her death.Experienced: cough, skin irritation, chest pressure, fluid build-up.

• Brand Name: CPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): RESPIRONICS, INC.
• MDR Report Key: 12984964
• MDR Text Key: 282193370
• Report Number: MW5105961
• 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 Family Member or Friend
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SYSTEM ONE 260P C-FLEX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Race: White