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

Model Number AU2110X15B

Device Problem Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2024

Event Type  malfunction  

Event Description

The manufacturer received information alleging a battery depleted alarm while the batteries were fully charged.There was no harm or injury reported.The ventilator was returned to the manufacturer for evaluation.The manufacturer lab reviewed the event log from the trilogy evo, australia device and noted e-44 and e-54 in the log.The lab then removed ac power and ran therapy on battery power until both the internal and detachable batteries were completely depleted to 0 capacity and then reapplied ac power and charged both batteries to 100% capacity without issue.After further review of the event log it was noted that this is an occurrence of trilogy evo defect# 484.The lab then reinstalled the batteries in the device, placed a red cap on the outlet port of the device and started therapy in cpap mode at 25 cmh2o and after 10:55 minutes simulated a breath and the device started alarming for batteries completely depleted while the batteries were fully charged.The device then corrected itself and then would show the correct charge level of the batteries on the display.The lab concluded that this is an occurrence of defect #484 and is a software issue with the device.

• Brand Name: TRILOGY EVO INTERNATIONAL
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer (Section G): RESPIRONICS, INC.; 1001 murry ridge lane; murrysville PA 15668
• Manufacturer Contact: kimberly shelly ; 6501 living place; pittsburgh, PA 15208 ; 4125423300
• MDR Report Key: 18686235
• MDR Text Key: 336209820
• Report Number: 2518422-2024-06836
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K181166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AU2110X15B
• Device Catalogue Number: AU2110X15B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1