MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY100 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	R1054655TP
Medical Device Problem Codes	Degraded (1153); No Display/Image (1183); Obstruction of Flow (2423); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging a trilogy 100 ventilator inoperative condition occurred.There was no harm or injury reported.A report was received from a visiting nurse, stating that when an alarm was supposed to sound, it did not sound, and the display was blank and indicated only the time of occurrence.The event first occurred when suction was being performed on a patient twice between 12:00pm and 3:00pm.The alarm which had usually sounded did not sound.The display was blank and indicated only the time.The issue was resolved by resetting the device.The second event occurred when the circuit was removed to wipe water inside the hose at 10:45pm.The customer states it is possible that this event occurred because they removed the circuit during suction.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Previously reported by the manufacturer: the manufacturer received information alleging a trilogy 100 ventilator inoperative condition occurred.There was no harm or injury reported.A report was received from a visiting nurse, stating that when an alarm was supposed to sound, it did not sound, and the display was blank and indicated only the time of occurrence.The event first occurred when suction was being performed on a patient twice between 12:00pm and 3:00pm.The alarm which had usually sounded did not sound.The display was blank and indicated only the time.The issue was resolved by resetting the device.The second event occurred when the circuit was removed to wipe water inside the hose at 10:45pm.The customer states it is possible that this event occurred because they removed the circuit during suction.The device has not yet been returned to the manufacturer for evaluation.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.New information/evaluation: the ventilator was returned to the manufacturer for evaluation and the customer¿s complaint was not confirmed.During the evaluation of the device at the manufacturer's service center, the event log was checked, and no alarm logs for "circuit disconnected", "low minute ventilation" or "low inspiratory pressure" were found.Using a circuit and accessories similar to the ones that had been in use at the time of the event, alarm activation verification was performed with a test lung being connected in the same ventilation settings, and it was confirmed that "circuit disconnected" and "low minute ventilation" alarms sounded.When functional test was performed, it was confirmed that some items for flow, (repair test 0030.0170 to 0290 and 0550 to 0630), resulted in fail.When the device was disassembled and internal checking was performed, it was confirmed that white powdery dirt adhered from the air intake to the blower.It is possible that the dirt inside the device impacted the fail for functional test.Since the alarm activation was confirmed at the abovementioned verification regarding the reported issue, the fail at functional test would not be the direct cause of the alarm not sounding issue, but it is possible that there may have been an impact.The device's sensor system board was replaced to address the issue.Regarding the issue of only the time was displayed when the alarm occurred, alarms were intentionally generated repeatedly and the screen display was checked at each time during the investigation period, but no issues such as the reported ones were not duplicated.Since the device passed functional test, it has been determined that there is no issue.Periodic maintenance 1 was performed.The following parts were replaced to prevent failure: pollen filter.Performed repair test, alarm check, battery check, run in tests and cleaning then confirmed the unit operated properly.Confirmed the software version is 14.1.0.Box h coding updated based on the outcome of the evaluation.

• Brand Name: TRILOGY100 VENTILATOR
• Common Device Name: 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: melissa rosko ; 1001 murry ridge lane; murrysville, PA ; 7247330200
• MDR Report Key: 22009418
• Report Number: 2518422-2025-105540
• Device Sequence Number: 5404847
• Product Code: CBK
• UDI-Device Identifier: 00606959025387
• UDI-Public: (01)00606959025387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R1054655TP
• Device Catalogue Number: R1054655TP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0882-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown