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

Patient Problems Pneumonia (2011); Respiratory Failure (2484)

Event Date 07/10/2021

Event Type  Death  

Event Description

My mother was on one of these machines that was recalled and she kept getting pneumonia and ultimately died from respiratory failure.She had stopped smoking 30 years before she passed away.

• Brand Name: TRILOGY BIPAP
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 18159385
• MDR Text Key: 328525901
• Report Number: MW5148236
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White