Philips Trilogy VentilatorRecalls & reported problems across all models
Respironics, Inc. · 90 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
22 open recalls name at least one Philips Trilogy Ventilator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 36,113
- Deaths reported
- 316
- Injuries reported
- 641
- Recalls
- 22
We found 90 models of Philips Trilogy Ventilator by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 36,113 adverse event reports in the FDA's MAUDE database, received between Sep 23, 2015 and Sep 30, 2026 — classified as 316 deaths, 641 injuries, 35,140 malfunctions.
The most frequently reported specific device problem is “Circuit Failure” (5,246 reports).
22 FDA recall records name at least one of these models by its device identifier, 22 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Philips Trilogy Ventilator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0293-2025 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0292-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0291-2025 · Root cause: Device Design · names 18 of these models · Recall details · FDA record ↗
- Oct 7, 2024Open, Classified
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Z-0290-2025 · Root cause: Device Design · names 11 of these models · Recall details · FDA record ↗
- Jul 16, 2024Open, Classified
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Z-2944-2024 · Root cause: Device Design · names 28 of these models · Recall details · FDA record ↗
- Jul 16, 2024Open, Classified
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Z-2943-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 16, 2024Open, Classified
Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.
Z-2942-2024 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1505-2024 · Root cause: Device Design · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1504-2024 · Root cause: Device Design · names 17 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1503-2024 · Root cause: Device Design · names 6 of these models · Recall details · FDA record ↗
- Mar 19, 2024Open, Classified
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Z-1502-2024 · Root cause: Device Design · names 7 of these models · Recall details · FDA record ↗
- Nov 27, 2023Open, Classified
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
Z-0638-2024 · Root cause: Device Design · names 24 of these models · Recall details · FDA record ↗
- May 25, 2023Open, Classified
There are errors present in the Korean Instructions For Use where the word "invasive," was incorrectly translated to "noninvasive".
Z-2106-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 1, 2023Open, Classified
The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and pulse rate data when integrated with the appropriate accessories. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.
Z-1652-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 1, 2023Open, Classified
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Z-1651-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- May 1, 2023Open, Classified
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Z-1650-2023 · Root cause: Under Investigation by firm · names 5 of these models · Recall details · FDA record ↗
- May 1, 2023Open, Classified
Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.
Z-1649-2023 · Root cause: Under Investigation by firm · names 7 of these models · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Z-1289-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Z-1288-2023 · Root cause: Under Investigation by firm · names 3 of these models · Recall details · FDA record ↗
- Mar 1, 2023Open, Classified
The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.
Z-1287-2023 · Root cause: Under Investigation by firm · names 10 of these models · Recall details · FDA record ↗
- Dec 7, 2022Open, Classified
The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.
Z-0882-2023 · Root cause: Process design · Recall details · FDA record ↗
- Dec 22, 2021Open, Classified
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.
Z-0493-2022 · Root cause: Mixed-up of materials/components · names 2 of these models · Recall details · FDA record ↗
Most reported Philips Trilogy Ventilator problems
Device problems
- Circuit Failure5,246
- Electrical /Electronic Property Problem4,737
- Battery Problem4,649
- Failure to Recalibrate3,991
- Mechanical Problem3,980
- Failure to Charge2,783
- Failure to Calibrate2,419
- Device Displays Incorrect Message2,120
Patient problems
- No Clinical Signs, Symptoms or Conditions25,054
- No Patient Involvement4,989
- No Consequences Or Impact To Patient4,877
- Unspecified Respiratory Problem354
- No Known Impact Or Consequence To Patient309
- Headache225
- Dizziness203
- Asthma147
Philips Trilogy Ventilator models
90 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trilogy Trilogy100 Ventilator, United StatesVENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USAVentilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USAVENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- 8 deaths2,493 reports
- Trilogy EV300, USA DS2200X11BContinuous, ventilator, home use5 recalls2,071 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE15 deaths2,059 reports
- Trilogy Trilogy O2 Ventilator JapanVENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- 2 deaths1,594 reports
- Trilogy Trilogy 202 Ventilator InternationalVENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- Trilogy Evo, Japan JP2110X16BContinuous, ventilator, home use5 recalls27 deaths1,112 reports
- Trilogy Trilogy Evo Ventilator, IntlCONTINUOUS, VENTILATOR, HOME USE4 recalls3 deaths648 reports
- Trilogy Evo KR2110X15BVentilator, continuous, facility use6 recalls3 deaths466 reports
- 696 reports
- 4 recalls5 deaths342 reports
- Trilogy Trilogy 100 Ventilator, ChinaVENTILATOR, CONTINUOUS, FACILITY USE1 death447 reports
- Trilogy Evo GB2110X15BContinuous, ventilator, home use5 recalls1 death141 reports
- Trilogy Evo FX2100X15BContinuous, ventilator, home use5 recalls1 death128 reports
- Trilogy Evo EE2110X15BContinuous, ventilator, home use5 recalls1 death85 reports
- Trilogy Evo FR2110X14BVentilator, continuous, facility use5 recalls77 reports
- Trilogy Trilogy Evo Ventilator with oxygen blending model, EUVENTILATOR, CONTINUOUS, FACILITY USE6 recalls16 reports
- Trilogy Evo DS2100X11BOximeter6 recalls2 deaths15 reports
- Trilogy Evo Universal DS2000X11BVentilator, continuous, facility use6 recalls12 reports
- 6 recalls9 reports
- Trilogy Evo EE2100X15BContinuous, ventilator, home use6 recalls5 reports
- 1 death304 reports
- 4 recalls94 reports
- Trilogy EV300 FX2200X15BContinuous, ventilator, home use5 recalls34 reports
- Trilogy Trilogy200 Ventilator, United StatesCONTINUOUS, VENTILATOR, HOME USE4 deaths282 reports
- Trilogy IT2110X21BANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls30 reports
- Trilogy Trilogy Evo Ventilator, GermanyANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls26 reports
- Trilogy Trilogy Evo Ventilator, EUVENTILATOR, CONTINUOUS, FACILITY USE4 recalls69 reports
- Trilogy Evo Trilogy Evo Ventilator with oxygen blending model, GermanyANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls9 reports
- Trilogy Evo Trilogy Evo, O2, IndiaVentilator, continuous, facility use5 recalls2 reports
- Trilogy Trilogy Evo Ventilation system w/oxygen blending model, ITVENTILATOR, CONTINUOUS, FACILITY USE5 recalls0 reports
- Trilogy Evo ND2100X15BVentilator, continuous, facility use5 recalls0 reports
- Trilogy Evo EU2100X19ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE5 recalls0 reports
- Trilogy Evo ND2110X15BContinuous, ventilator, home use4 recalls37 reports
- Trilogy Evo BL2110X15BANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE4 recalls28 reports
- Trilogy Evo CA2110X12BVentilator, continuous, facility use4 recalls23 reports
- Trilogy Evo AU2110X15BVentilator, continuous, facility use3 recalls3 deaths54 reports
- Trilogy 100 Trilogy100 Ventilator, Bluetooth, InternationalVENTILATOR, CONTINUOUS, FACILITY USE1 death186 reports
- Trilogy Evo TR2110X15BVentilator, continuous, facility use3 recalls9 reports
- 154 reports
- 1 death154 reports
- Trilogy Evo EU2110X19Continuous, ventilator, home use3 recalls0 reports
- Trilogy 100 Trilogy100 Ventilator, Bluetooth, ItalyMedical device data system146 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE1 death135 reports
- 129 reports
- Trilogy Trilogy 100 Ventilator, BrazilVENTILATOR, CONTINUOUS, FACILITY USE2 deaths127 reports
- Trilogy 00Oximeter4 deaths119 reports
- Trilogy Trilogy200 Ventilator, InternationalCONTINUOUS, VENTILATOR, HOME USE104 reports
- Trilogy Trilogy100 Ventilator, AustraliaVENTILATOR, CONTINUOUS, FACILITY USE97 reports
- Trilogy 200 Trilogy 200 Bluetooth, U.S.A.VENTILATOR, CONTINUOUS, FACILITY USE92 reports
- 84 reports
- 81 reports
- Trilogy 00CONTINUOUS, VENTILATOR, HOME USE63 reports
- Trilogy Trilogy 100 w/Bluetooth, U.S.AVENTILATOR, CONTINUOUS, FACILITY USE1 recall12 reports
- Trilogy 200 Trilogy 200 Ventilator, Japan-RentalVENTILATOR, CONTINUOUS, FACILITY USE2 deaths56 reports
- Trilogy Evo Trilogy Evo, PostponementVENTILATOR, CONTINUOUS, FACILITY USE1 recall0 reports
- Trilogy 00VENTILATOR, CONTINUOUS, FACILITY USE46 reports
- 1 death32 reports
- Trilogy Trilogy200 Ventilator, Latin AmericaCONTINUOUS, VENTILATOR, HOME USE25 reports
- Trilogy 200 Trilogy 200 Ventilator, Bluetooth, CanadaCONTINUOUS, VENTILATOR, HOME USE23 reports
- Trilogy Trilogy202 Ventilator, BrazilVENTILATOR, CONTINUOUS, FACILITY USE22 reports
- Trilogy Trilogy EC, U.S.AVENTILATOR, CONTINUOUS, FACILITY USE20 reports
- Trilogy 200 Trilogy200, Aeris 200, BluetoothCONTINUOUS, VENTILATOR, HOME USE2 deaths17 reports
- Trilogy 100 Trilogy100 Ventilator, Bluetooth, CanadaVENTILATOR, CONTINUOUS, FACILITY USE16 reports
- 15 reports
- Trilogy 00Oximeter15 reports
- Trilogy Trilogy202 Ventilator, KoreaVENTILATOR, CONTINUOUS, FACILITY USE14 reports
- Trilogy Trilogy 200 Ventilator, U.S.A.-RecertVENTILATOR, CONTINUOUS, FACILITY USE14 reports
- Trilogy U1054260BOximeter14 reports
- Trilogy Trilogy 202 Ventilator, U.S.A.-RENTALVENTILATOR, CONTINUOUS, FACILITY USE13 reports
- Trilogy 200 Trilogy 200 Ventilator, Italy, BluetoothMedical device data system13 reports
- 10 reports
- Trilogy Trilogy 200 Ventilator, U.S.A.-RentalVENTILATOR, CONTINUOUS, FACILITY USE9 reports
- Trilogy 200 Trilogy200, Ventilator, Bluetooth, InternationalVENTILATOR, CONTINUOUS, FACILITY USE9 reports
- TRILOGY TRILOGY 202 VENTILATOR, U.S.A-RECERTVENTILATOR, CONTINUOUS, FACILITY USE7 reports
- 7 reports
- Trilogy 206 00VENTILATOR, CONTINUOUS, FACILITY USE6 reports
- Trilogy 100 Trilogy 100 Ventilator, Bluetooth, AustraliaCONTINUOUS, VENTILATOR, HOME USE5 reports
- Trilogy R1054260BContinuous, ventilator, home use4 reports
- Trilogy 00VENTILATOR, CONTINUOUS, FACILITY USE3 reports
- Trilogy U1040005BContinuous, ventilator, home use3 reports
- 2 reports
- Trilogy 100 Trilogy 100 Ventilator, Korea (Vitalaire)CONTINUOUS, VENTILATOR, HOME USE2 reports
- Trilogy RSL1054260BVentilator, continuous, facility use1 report
- Trilogy RTO1054260BOximeter1 report
- 1 report
- Trilogy Evo FX2110X15BContinuous, ventilator, home use1 report
Recent Philips Trilogy Ventilator adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952648 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952644 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952153 ↗MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951901 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951679 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
The manufacturer received information that a Trilogy Evo ventilator was returned to a third-party service center for evaluation. There was no patient involvement, and no harm or injury reported.On evaluation, a critical event code that indicates the power VBUS dropped was recorded in the event log; the system printed circuit board assembly was replaced. Preventative maintenance was completed. Cosmetic damage was reported and components replaced. The device passed final testing and was returned to the customer.Additional findings not related to the malfunction/issue: A non-critical event code was noted in the event log indicating replacement of the machine flow was sensor was required; the machine flow sensor was replaced.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951504 ↗MalfunctionSep 30, 2026Mechanical Problem
The manufacturer received information alleging a failed test step occurred on a Trilogy EV300 ventilator. The device was not in use on a patient at the time of the occurrence.The Trilogy EV300 ventilator was evaluated by a third-party service center (General Biomedical Service Inc) and the customer¿s states the preventative maintenance is failing the AECM portion of the System Final test. The manufacturer Remote Service Engineer reviewed the service manual and suggested repair for the failed test. The customer is taking responsibility to correct/repair the device. The remote service engineer noted: The system does not meet the specification for the performed service and is not returned to use.The customer has been notified to contact Philips if the repair recommendations does not address the device issue at which point a new service order will be created. The Remote Service Engineer noted: No further information will be obtained as this concluded Philips remote support to the customer for this event.A Good Faith Effort attempt will be made to gather additional information from the customer regarding the repair of the device. If additional information becomes available, a supplement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951015 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
The manufacturer received a report that a Trilogy EVO ventilator was returned for service. No patient harm or injury was reported.The device was evaluated at a third-party service center. The device log files were successfully downloaded and reviewed in full. Review of the logs identified a Vent Service Required error indicating that the device software detected a large pressure drop between the monitor and outlet pressure sensors. The air pathway was inspected for environmental debris and contamination; no debris or contamination was identified. Service documentation did not identify the component replaced to address this condition. Additional error conditions, unrelated to the reported malfunction, were identified during the evaluation. An error related to the machine flow sensor offset being greater than 0.2 SLPM was identified. In accordance with the service manual, the machine flow sensor was replaced.An error related to the main outlet pressure sensor encountering an error condition was also identified requiring replacement of the System Printed Circuit Assembly (PCA).An error related to the sensor offset during drift calculation being too high was identified. A pneumatic gro
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951013 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
The manufacturer received information alleging a power v_bus dropped error code had occurred on a Trilogy EVO device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error code, event power vbus dropped, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event power vbus dropped error code. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue. The root cause isn't confirmed at this time.A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951010 ↗MalfunctionSep 30, 2026Circuit Failure; Failure to Calibrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951009 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950685 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Device Sensing Problem
The manufacturer received a report from a customer that a Trilogy Evo ventilator was experiencing frequent ¿Ventilator Service Required¿ alarms. No patient harm or injury was alleged in association with the reported condition.The device was replaced and evaluated. During the operational check, the reported ¿Ventilator Service Required¿ alarm was reproduced. Review of the device logs identified error code 385-EVT_MACH_FLOW_DRFT_VSR, indicating that the amount of variation in the flow sensor had deviated from specification. The flow sensor was replaced. Dirt was also observed within the airflow path during the evaluation. Additionally, the 3-way solenoid valve was replaced after the cable was found to have been damaged by being caught in the device cover. No thermal damage or exposed wiring was observed.Following the repairs, the device successfully completed the final test, battery check, valve check, and run-in testing. The device was cleaned and confirmed to be operating properly. The device software version was confirmed to be 1.06.15.00.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950010 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949245 ↗MalfunctionSep 30, 2026Failure to Power Up
A device was returned to a service center in reference to the voluntary Field Safety Notice / recall notification related to the sound abatement foam in certain CPAP, BiPAP, and mechanical ventilator devices. There was no harm or injury reported.During the evaluation of the device at the third-party service center, the device was visually inspected and found no evidence of foam degradation. However, it was reported that the device failed to power on for evaluation and testing. It was reported the device was scrapped without further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949244 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
The manufacturer received information alleging a power v_bus dropped error code had occurred on a Trilogy EVO device. The device was not in use on a patient at the time of the occurrence. During the evaluation it was noted that an error code, event power vbus dropped, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event power vbus dropped error code. Another error code, event soft power fail, was observed on the device's error log. The third-party service technician provided no documentation stated on a root cause and/or any component replacement to resolve the event soft power fail error code. There was no repair information was provided, and no part(s) were replaced to address this issue due to the customer request to scrap the device. The root cause isn't confirmed at this time.A final report is being submitted. If new information becomes available following the completion of the device repair that changes the outcome of the investigation and associated medical device reporting a supplemental report will be completed. Additionally, during the service of th
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949243 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips DreamStation190 models · 32,422 reports
- Trilogy46 models · 21,644 reports · 11 recalls
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
- BiPAP autoSV Advanced System One 60 Series19 models · 1,166 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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