MAUDE Adverse Event Report: RESPIRONICS INC TRILOGY 202; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 1040000

Device Problems Inaccurate Delivery (2339); Insufficient Information (3190)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/18/2021

Event Type  Injury  

Event Description

The manufacturer received information alleging a ventilator was not delivering oxygen properly and a patient's blood oxygen saturation dropped while on the device.The patient was placed on a different ventilator in response to the event.A request has been made to the customer to have the device returned to the manufacturer's quality product investigation laboratory; however, at this time the device has yet to be returned for evaluation, and we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The manufacturer previously reported receiving information alleging a ventilator was not delivering oxygen properly and a patient's blood oxygen saturation dropped while on the device.The ventilator was exchanged for another device in response to the event.The device was returned to the manufacturer's quality product investigation laboratory for evaluation, and the customer's complaint was confirmed.During the evaluation, the device failed steps during testing and a "service required" code was found in the ventilator's downloaded event log.The manufacturer concludes the root cause is related to a failure of the c27 component on the device's interface board.The device's interface board needs replaced to address the issue.

• Brand Name: TRILOGY 202
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11399385
• MDR Text Key: 234268091
• Report Number: 2518422-2021-00596
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959022706
• UDI-Public: 00606959022706
• Combination Product (y/n): N
• PMA/PMN Number: K093905
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1040000
• Device Catalogue Number: 1040000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention