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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/22/2021

Event Type  Injury  

Event Description

My mother experienced a critical decrease in o2 levels was rushed to hospital.Fda safety report id # (b)(4).

• Brand Name: TRILOGY MACHINE
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC.
• MDR Report Key: 12406047
• MDR Text Key: 269543240
• Report Number: MW5103622
• Device Sequence Number: 1
• Product Code: NOU
• 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: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR