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

Model Number 1054655

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 06/01/2020

Event Type  Death  

Event Description

The manufacturer received information indicating a patient expired while using a trilogy ventilator.Information obtained indicated a circuit disconnect alarm condition occurred while in use.The caregivers acknowledged the device was alarming to alert the caregivers of an alarm condition, but did not respond to the audible alarm.The device was returned to the manufacturer for investigation.During the investigation, the ventilator's downloaded event logs were reviewed by the manufacturer and the manufacturer confirmed that the device alarmed appropriately at the time of the incident to alert the caregiver.The device was tested and found to operate to design specifications.There were no issues found with the device and the device passed all testing.There is no evidence to suggest the device caused or contributed to the noted event.The device maintains the event logs in non-volatile memory.An event, as logged by the device, includes every keypress, alarm or failure of the device to remain within specifications.There were no events logged related to device performance or device malfunctions.If a device malfunction occurred, the event logs would have contained entries related to the malfunction.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
• Manufacturer (Section G): RESPIRONICS, INC; 1001 murry ridge lane; murrysville, pa
• Manufacturer Contact: adam price ; 312 alvin dr; new kensington, pa ; 3349303
• MDR Report Key: 10188713
• MDR Text Key: 196226042
• Report Number: 2518422-2020-01390
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083526
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1054655
• Device Catalogue Number: 1054655
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2020
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 62 YR