MAUDE Adverse Event Report: RESPIRONICS INC. TRILOGY EVO; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number FX2100X15B

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Respiratory Failure (2484)

Event Date 04/16/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a patient became disconnected from a ventilator and expired.The manufacturer is currently investigating this event and a follow up report will be filed when the investigation is complete.

Manufacturer Narrative

It was initially reported, a patient became disconnected from the device and expired.The manufacturer received the ventilator's downloaded event logs from the reporter of the event.On the day of the event, (b)(6) 2021, a low oxygen inlet pressure alarm occurred with a duration of 2791 seconds, approximately 46 minutes.An oxygen regulation alarm also occurred with a duration of 2641 seconds, approximately 44 minutes.These alarms were acknowledged as evidenced by an alarm silence key press.The ventilator was being used with 85% oxygen.These alarms indicate the oxygen flow was inadequate for the ventilator to supply 85% oxygen to the patient.The alarms are indicative of a large leak, such as a patient circuit disconnect.Other alarms including the patient circuit disconnect and low minute ventilation were turned off at the time of the event.No events were logged that would indicate a device malfunction or failure to deliver therapy occurred.The manufacturer concludes the device operated and alarmed as designed.

• Brand Name: TRILOGY EVO
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC.; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11693701
• MDR Text Key: 246262020
• Report Number: 2518422-2021-01131
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959061019
• UDI-Public: 00606959061019
• Combination Product (y/n): N
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FX2100X15B
• Device Catalogue Number: FX2100X15B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death