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

Model Number FR2110X14B

Device Problems Circuit Failure (1089); Contamination (1120); Mechanical Problem (1384); Insufficient Information (3190)

Patient Problem Respiratory Arrest (4461)

Event Date 12/08/2020

Event Type  Injury  

Event Description

The manufacturer received information alleging that a ventilator alarmed for exhalation valve failure while on a patient.The patient developed respiratory insufficiency and required respiratory resuscitation with a manual bag resuscitation device.The patient was transferred to the intensive care unit and required prolonged hospitalization due to the event.No further information is available at this time.The device has yet to be returned to the manufacturer for evaluation.At this time, 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 that a ventilator alarmed for exhalation valve failure while on a patient.The patient developed respiratory insufficiency and required respiratory resuscitation with a manual bag resuscitation device.The patient was transferred to the intensive care unit and required prolonged hospitalization due to the event.The device was returned to the manufacturer's quality product investigation lab for evaluation.During the evaluation, a "service required" code alarm condition related to the device's active exhalation valve was observed in the ventilator's downloaded event log.An examination of the device's active exhalation valve revealed excess fluid in the diaphragm and tubing of the active exhalation valve.The manufacturer was able to confirm the complaint of active exhalation valve failure.The manufacturer concludes the root cause of the active exhalation valve failure is excess water in the device's active exhalation valve diaphragm and tubing.The excess water likely prevented the active exhalation valve from opening and closing properly.The manufacturer also received the circuit and valve that were used during this event.The f&p circuit and intersurgical valve that were returned with the device are not on the manufacturer's list of approved accessories for use with the trilogy evo device.A review of the ventilator's downloaded event log showed multiple patient circuit and error alarms on the date of the reported event which occurred from the time the device was powered on.These alarms were either not acknowledged or were silenced as evidenced in the device's downloaded event logs.The trilogy evo device was evaluated and found to operate and alarm as designed on the manufacturer's multifunction test station.The device passed all testing and performed to specifications.The manufacturer has determined that the trilogy evo device works as designed but when the device is connected to the patient circuit that was returned with the device, the performance of the device is diminished due to the fluid in the diaphragm and tubing which causes the failure.In addition to the above information, a "service required" code was found in the ventilator's downloaded error log related to the device's system board.The device's system board needs replaced to address the issue.

• 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: 11138842
• MDR Text Key: 225727862
• Report Number: 2518422-2021-00045
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00606959055506
• UDI-Public: 00606959055506
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FR2110X14B
• Device Catalogue Number: FR2110X14B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention