Newport E360E-JP-NARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521540941), received between Jul 19, 2017 and Mar 17, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “No Flow” (6 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE E360 VENTILATOR GENERATED AN ALARM, THE SCREEN OF THIS UNIT BLACKED OUT AND THE VENTILATION STOPPED WHILE THE PATIENT WAS CONNECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919136 ↗
• MalfunctionOct 2, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE E360 VENTILATOR HAD BLANK SCREEN WITH AUDIO ALARM AND STOPPED VENTILATION. IT WAS ALSO STATED THAT THE SCREEN DISPLAYED NORMALLY WHEN THE DEVICE WAS TURNED OFF AND TURNED ON AGAIN. 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 9147516 ↗
• MalfunctionSep 17, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE E360 VENTILATOR'S GUI (GRAPHIC USER INTERFACE) WENT BLANK WITH AN ALARM AND STOPPED VENTILATION. IT WAS ALSO NOTED THAT THE DEVICE EMITTED A BURNT SMELL. 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 9079762 ↗
• MalfunctionJan 29, 2019No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT, THE E360 VENTILATOR GENERATED AN ALARM, A COMMUNICATION ERROR MESSAGE WAS DISPLAYED, VENTILATION STOPPED AND THERE WAS A POWER OFF ISSUE. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED. LATER, A HOSPITAL MEDICAL DEVICE ENGINEER INSPECTED THE DEVICE AND CONFIRMED THAT THERE WAS A "NO COMMUNICATIONS" ERROR RECORDED IN THE VENTILATOR LOGS. ADDITIONALLY IT WAS NOTED THAT THE VENTILATOR'S TIME WAS 12 HOURS AHEAD. THERE WAS NO POWER OFF ISSUE RECORDED IN THE EVENT HISTORY.

  Patient problems: No Code Available

  MAUDE report 8287233 ↗
• MalfunctionOct 26, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE E360 VENTILATOR STOPPED VENTILATION ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED. AFTER REMOVAL OF THE PATIENT, THE VENTILATOR WAS RESTARTED AND DISPLAYED A "NO COMMUNICATIONS" ERROR MESSAGE.

  Patient problems: No Code Available

  MAUDE report 8010186 ↗
• MalfunctionOct 22, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE E360 VENTILATOR GENERATED AN ELECTRONIC ALARM SOUND AND THE SCREEN TURNED BLACK. ADDITIONALLY, IT WAS REPORTED THAT WHEN THE PATIENT CIRCUIT WAS DISCONNECTED, THE VENTILATOR¿S SETTING DISPLAY ILLUMINATED, AND IT WAS NOTICED THAT THERE WAS NO GAS BEING DELIVERED FROM THE INSPIRATORY PORT OF THE VENTILATOR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7993332 ↗
• MalfunctionApr 12, 2018Thermal Decomposition of Device; Device Inoperable; Thermal Decomposition of Device; Device Inoperable

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE E360 VENTILATOR GENERATED A CONTINUOUS ALARM, THE DISPLAY MONITOR WAS BLOCKED OUT, VENTILATION STOPPED AND THERE WAS A BURNT SMELL. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO PATIENT HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7426985 ↗
• MalfunctionAug 17, 2017Low Battery; Low Battery

  IT WAS REPORTED THAT THE E360 VENTILATOR DISPLAYED A LOW BATTERY ERROR MESSAGE DURING BATTERY DRIVE TEST. PATIENT INVOLVEMENT WAS NOT PROVIDED.

  Patient problems: No Information

  MAUDE report 6801002 ↗
• MalfunctionAug 16, 2017Low Battery; Low Battery

  IT WAS REPORTED THAT AT A TIME OF MAINTENANCE E360 VENTILATOR GENERATED A LOW BATTERY ALARM. THERE WAS NO PATIENT INVOLVEMENT REPORTED AT THE TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6798183 ↗
• MalfunctionJul 31, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING THE BATTERY DRIVE TEST, THE E360 VENTILATOR SHUT DOWN. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE BATTERY NEEDED TO BE REPLACED. MEDTRONIC/COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN MEDTRONIC/COVIDIEN CONTROL. THE REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC/COVIDIEN 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 6753913 ↗
• MalfunctionJul 19, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A LEAK. 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 WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE ENGINEER (SE) CONFIRMED THE LEAK AND REPLACED THE WATER TRAP. THE ISSUE WAS CORRECTED. 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 6726333 ↗