MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. PHILIPS RESPIRONICS CPAP TRILOGY; CONTINUOUS, VENTILATOR, HOME USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Cancer (3262)

Event Date 03/01/2020

Event Type  Injury  

Event Description

Stage 3 lung cancer diagnosed around (b)(6) 2020.She got a philips respironics cpap trilogy in (b)(6) 2019 and developed cancer in (b)(6) 2020.

• Brand Name: PHILIPS RESPIRONICS CPAP TRILOGY
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 13289615
• MDR Text Key: 284147523
• Report Number: MW5106743
• Device Sequence Number: 1
• Product Code: NOU
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/01/2024
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DUPIXENT ; METFORMIN ; PREDNISONE; ROSUVASTATIN
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Other; Disability
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White