Newport E360E-CN-NARecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521540910), received between Aug 14, 2017 and Nov 26, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 26, 2025Defective Alarm; Defective Alarm

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE SCREEN OF THIS 840 VENTILATOR HAD "FROZEN", PARAMETERS COULD NOT BE ADJUSTED, RESPIRATORY WAVEFORM REMAINED UNCHANGED, BUT DEVICE DID NOT ISSUE ANY ALARMS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658351 ↗
• MalfunctionOct 21, 2022Smoking; Smoking

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE E360 VENTILATOR GENERATED AN ALARM ACCOMPANIED BY "SCORCHED SMOKE AND ODOR". THE PATIENT OUTCOME AND INTERVENTION ARE UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 15651582 ↗
• MalfunctionAug 25, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS E360 VENTILATOR WAS IN A "DEAD STATE" AND SCREEN PARAMETERS COULD NOT BE CHANGED AND THE PATIENT'S OXYGEN SATURATION DECREASED BUT IT WAS IMPROVED AFTER REPLACING THE VENTILATOR.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15298991 ↗
• MalfunctionJul 26, 2022Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE E360 VENTILATOR WAS NOT DELIVERING AIR, AND THE UNIT HAD NEITHER ALARM SOUND OR LIGHT. IT WAS ALSO REPORTED THAT THE SATURATION CONCENTRATION OF BLOOD OXYGEN OF THE PATIENT DECREASED. ALTHOUGH REQUESTED, THE INFORMATION REGARDING PATIENT INTERVENTION WAS NOT PROVIDED. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15108629 ↗
• MalfunctionJan 26, 2021No Flow; No Flow

  IT WAS REPORTED THAT THE PATIENT DEVELOPED CYANOSIS, RESTLESSNESS, AND DECREASED HEART RATE AFTER 24-HOUR USE OF THE E360 VENTILATOR. ADDITIONALLY, IT WAS REPORTED THAT THE VENTILATOR DID NOT ALARM AND VENTILATION STOPPED. THE MEDICAL STAFF IMMEDIATELY DISCONNECTED THE VENTILATOR AND PROVIDED MANUAL VENTILATION VIA BALLOON TO ASSIST IN BREATHING. THE PATIENT WAS NOT ASPIRATED DUE TO THE EVENT, BUT WAS PLACED ON AN ALTERNATE VENTILATOR.

  Patient problems: Bradycardia; Cyanosis

  MAUDE report 11231770 ↗
• MalfunctionJan 28, 2020No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, AN E360 VENTILATOR SHUT DOWN UNEXPECTEDLY, HAD NO DISPLAY AND WAS NOT VENTILATING. THE PATIENT WAS REMOVED FROM THE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9640163 ↗
• MalfunctionJan 17, 2020No Flow; No Flow

  IT WAS REPORTED BY THE (B)(6) FOOD AND DRUG ADMINISTRATION (B)(6) THAT WHILE IN USE THIS E360 VENTILATOR SCREEN WAS WHITE, ALARMED AND THE VENTILATOR STOPPED SUPPLYING AIR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9603485 ↗
• MalfunctionSep 23, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE E360 VENTILATOR'S SCREEN DISAPPEARED AND STOPPED VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106415 ↗
• MalfunctionAug 8, 2019No Flow; No Flow

  ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT EXPERIENCED TACHYPNEA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875950 ↗
• MalfunctionAug 24, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR OXYGEN (O2) WATER TRAP/FILTER WAS LEAKING WHEN CONNECTED TO THE O2 SOURCE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE O2 WATER TRAP ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6818855 ↗
• MalfunctionAug 24, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR OXYGEN (O2) WATER TRAP/FILTER WAS LEAKING WHEN CONNECTED TO THE O2 SOURCE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE O2 WATER TRAP ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6818791 ↗
• MalfunctionAug 16, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE SET-UP, THE E360 VENTILATOR HAD A SOUND OF GAS LEAKAGE IN O2 INLET. WHEN O2 GAS SUPPLY WAS DISCONNECTED THERE WAS NO LEAKAGE SOUND. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6798065 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SET UP THE E360 VENTILATOR HAD AN OXYGEN (O2) LEAK. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6792858 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SET UP THE E360 VENTILATOR HAD AN OXYGEN (O2) LEAK. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6792792 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SETUP THE E360 VENTILATOR HAD A SOUND OF GAS LEAKAGE IN THE OXYGEN (O2) INLET. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE PROVIDER DISCONNECTED THE O2 GAS SUPPLY SO THERE WAS NO LEAKAGE SOUND.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 6792586 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SETUP THE E360 VENTILATOR HAD A SOUND OF GAS LEAKAGE IN OXYGEN (O2) INLET. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE PROVIDER DISCONNECTED O2 GAS SUPPLY SO THERE WAS NO LEAKAGE SOUND.

  Patient problems: No Patient Involvement

  MAUDE report 6792323 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SETUP THE E360 VENTILATOR HAD A SOUND OF GAS LEAKAGE IN OXYGEN (O2) INLET. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE PROVIDER DISCONNECTED O2 GAS SUPPLY SO THERE WAS NO LEAKAGE SOUND.

  Patient problems: No Patient Involvement

  MAUDE report 6792283 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING SETUP THE E360 VENTILATOR HAD SOUND OF GAS LEAKAGE IN O2 INLET. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE PROVIDER DISCONNECTED O2 GAS SUPPLY SO THERE WAS NO LEAKAGE SOUND.

  Patient problems: No Patient Involvement

  MAUDE report 6792173 ↗