MAUDE Adverse Event Report: PHILIPS / RESPIRONICS, INC. RESPIRONICS TRILOGY 100; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Unexpected Shutdown (4019)

Patient Problem Death (1802)

Event Date 07/14/2020

Event Type  Death  

Event Description

Ventilator found off and resident expired.Fda safety report id# (b)(4).

• Brand Name: RESPIRONICS TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): PHILIPS / RESPIRONICS, INC. ; murraysville PA
• MDR Report Key: 10307357
• MDR Text Key: 199989327
• Report Number: MW5095637
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR
• Patient Weight: 57