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

Model Number 1054260

Device Problems No Audible Alarm (1019); Insufficient Information (3190)

Patient Problem Respiratory Failure (2484)

Event Date 03/10/2021

Event Type  Death  

Event Description

The manufacturer received information alleging a ventilator failed to alarm when a patient's tracheostomy cannula became dislodged and the patient expired.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the allegation.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 failed to alarm when a patient's tracheostomy cannula became dislodged and the patient expired.The device was returned to the manufacturer's product investigation laboratory for investigation.The ventilator's downloaded event logs were reviewed by the manufacturer and the manufacturer confirmed that the device did alarm appropriately to alert the caregiver.The device was tested on the manufacturer's multifunction test station and passed all testing.The manufacturer concludes the ventilator operated and alarmed as designed and did not cause or contribute to the reported event.

• Brand Name: TRILOGY 100
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS INC; 1001 murry ridge lane; murrysville PA 15668
• MDR Report Key: 11595861
• MDR Text Key: 243154254
• Report Number: 2518422-2021-00930
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959026353
• UDI-Public: 00606959026353
• Combination Product (y/n): N
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1054260
• Device Catalogue Number: 1054260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 46 YR