Newport E360S-CN-NARecalls & reported problems
Newport Medical Instruments, Inc. · e360 VENTILATOR, S MODEL CHINESE NA POWER · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521541078), received between May 2, 2019 and Jan 7, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “No Flow” (2 reports).
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
- No Flow2
Patient problems
- Bradycardia1
- Low Oxygen Saturation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2022No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THIS E360 VENTILATOR GENERATED AN ALARM AND POWER DISCONNECTED MESSAGE, THE VENTILATOR STOPPED DELIVERING BREATHS TO THE PATIENT AND AUTOMATICALLY SHUTS DOWN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13193699 ↗InjuryMay 2, 2019No Flow; No Flow
IT WAS REPORTED THAT DURING PATIENT USE, THE E360 VENTILATOR STOPPED VENTILATING THE PATIENT. THE PATIENT'S HEART RATE DECREASED TO 30 BEATS PER MINUTE AND THE SPO2 (PERIPHERAL CAPILLARY OXYGEN SATURATION) WAS UNABLE TO BE MONITORED. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED IMMEDIATELY AND THE PATIENT'S HEART RATE RECOVERED TO 110 BEATS PER MINUTE WITH AN INCREASE IN THE SPO2 TO 99%. ADDITIONALLY, IT WAS NOTED PATIENT WAS TREATED WITH CHEST COMPRESSION AND TRANSFERRED TO STANDBY VENTILATOR.
Patient problems: Bradycardia; Low Oxygen Saturation
MAUDE report 8575989 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
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- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
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- 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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