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

Model Number IN2100X15B

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 07/24/2020

Event Type  Death  

Event Description

The manufacturer received information alleging a patient expired while the ventilator was in use.The patient was admitted for covid 19 pneumonia and was placed on the ventilator.The patient later expired after resuscitation efforts were unsuccessful.The device has not yet been returned to the manufacturer.At this time, we are unable to confirm a malfunction of the device.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported a patient expired while in use.The device was returned to the manufacturer's product investigation laboratory for investigation.The device's were put through extensive testing which include a multi-function test station and altitude chamber which simulates the altitude environment used.Device evaluation also included a review of the device's downloaded event logs during clinical use.The investigations for these device's are completed and it was determined the devices operated as designed.The manufacturer concludes that the ventilator's operated and alarmed to design specifications and did not cause or contribute to the reported event.

• Brand Name: TRILOGY EVO
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC; 1001 murry ridge rd; murrysville, pa
• MDR Report Key: 10345103
• MDR Text Key: 201033125
• Report Number: 2518422-2020-01803
• Device Sequence Number: 1
• Product Code: CBK
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IN2100X15B
• Device Catalogue Number: IN2100X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 70 YR