MAUDE Adverse Event Report: RESPIRONICS, INC. TRILOGY EVO, O2, JAPAN; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	JP2100X16B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyanosis (1798); Low Oxygen Saturation (2477)
Date of Event	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received information alleging that a patient using a trilogy evo o2 ventilator experienced a 'low inspiratory pressure' alarm and that airflow stopped during use.Additionally, it is believed that a 'circuit disconnected' alarm did not sound.The patient experienced a decrease in spo2 and cyanosis appeared.The patient was switched to an ambu bag and the patient recovered.The clinical assessment team initially evaluated the complaint as a non-serious injury.The complaint has since been reassessed and the clinical assessment team states that 'this notification was reviewed due to a report of a call stating on 11/22/2024 at 13:33, the patient was going to take a bath.The patient takes a bath with the device on; so, they moved to the bathroom after removing the ac power.The device was covered with a plastic bag to prevent getting wet.At 13:49 the device was removed from the patient temporarily, then was put on them soon.At 15:54 a "low inspiratory pressure" alarm went off, and the airflow stopped during use on the patient.At 15:59 the patient had an unspecified decrease in spo2 and cyanosis appeared.The patient was switched to ambu bag and the patient recovered.After a while, the device seemed to operate properly, so it was put on the patient again.There were no problems with using it after that.The visiting nurse stated, ¿oxygen levels dropped because no airflow was supplied.The patient recovered quickly after switching to ambu bag.¿ the sales representative reported that although there were no significant leaks, ¿low inspiratory pressure¿ alarm sounded during use the device with the pressure support system.The cause is unknown.They said that there was no sign of a plastic bag being sucked in, and it seemed that no air was being supplied.It is believed that "circuit disconnected" alarm did not sound.' 'based on information available at the time of this review, there is sufficient evidence to pronounce this event of an unspecified spo2 desaturation and cyanosis as serious injuries, as defined in 21 cfr 803.3(w).' 'no causal relationship of the device to the patient outcome has been found, however contribution of the device to the patient adverse event cannot be confirmed, nor refuted, based on the evidence present.It is unclear if the plastic bag could have prevented the device from delivering appropriate therapy to the patient.' during evaluation of the device at the manufacturer's service center, the issue was not duplicated during an operational check.The service technician notes that three not-reportable error codes relating to 'low inspiratory pressure, 'low minute ventilation' and 'circuit disconnected' were found in the device's error log.There were no errors indicating any abnormalities, including obstruction, were observed.There were no abnormalities found after performing an internal inspection and functional testing.The waveform data shows that an observed leakage occurred.It is also noted that in the waveform data it shows that airflow was supplied during the issue.It is speculated that the issue was caused by external factors, such as leakage, and it is determined that there were no abnormalities with the device.Additionally, a noise occurred from the blower assembly.The blower was replaced to resolve the noise.Final testing, battery check, valve check, run in testing, and cleaning were performed.The unit operated properly.
Additional Manufacturer Narrative
The reported low inspiratory pressure error is accommodated in the product risk management file as being linked to hazard with description patient exposure to function / deterioration of function.Complaints for this failure are reviewed via the post market complaint trending and escalation processes to assess for the observed probability levels and compare them with the predicted levels in the risk file for the hazards linked to the failure.As of the date of submission for this report, there is no indication that complaints for the failure in question has led to unacceptable increase in probability levels for the hazardous situations in scope, and therefore no further action will be pursued.Qa continues to monitor complaints for this issue per the cadence in the complaint trending procedures.

• Brand Name: TRILOGY EVO, O2, JAPAN
• 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: 24897311
• Report Number: 2518422-2026-010942
• Device Sequence Number: 12963202
• Product Code: CBK
• UDI-Device Identifier: 00606959055582
• UDI-Public: (01)00606959055582
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: JP2100X16B
• Device Catalogue Number: JP2100X16B
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown