Newport E360E-RU-INRecalls & reported problems
Newport Medical Instruments, Inc. · e360 Ventilator with Accessories;E Model · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521540958), received between Apr 20, 2017 and May 30, 2017 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Battery Problem1
- Defective Component1
- Insufficient Device Problem Information1
Patient problems
- No Information2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2017Defective Component; Defective Component
IT WAS REPORTED THAT THE E360 VENTILATOR'S AIR SENSOR OF THE MOTHERBOARD WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT. THE MOTHERBOARD WAS REPLACED AND A 5000K PREVENTATIVE MAINTENANCE (PM) WAS PERFORMED ALONG WITH CALIBRATIONS AND ALL TESTS PASSED.
Patient problems: No Patient Involvement
MAUDE report 6600107 ↗MalfunctionApr 20, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT E360 VENTILATOR HAD A BAD BATTERY. PATIENT INVOLVEMENT IS UNKNOWN. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BATTERY. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN.
Patient problems: No Information
MAUDE report 6508000 ↗MalfunctionApr 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT E360 VENTILATOR HAD A DEFECTIVE OXYGEN SENSOR. PATIENT INVOLVEMENT IS UNKNOWN. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED. THE SERIAL NUMBER OF THE VENTILATOR WAS NOT PROVIDED THEREFORE THE DEVICE MANUFACTURE DATE IS UNKNOWN.
Patient problems: No Information
MAUDE report 6507967 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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