Newport E360E-WW-INRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10884521540989), received between Apr 3, 2017 and Jul 7, 2021 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2021Smoking; Contamination /Decontamination Problem; Smoking; Contamination /Decontamination Problem

  THERE WAS NO SMOKE SEEN. IT WAS REPORTED THAT AN "UNSPECIFIED SMELL" WAS NOTED NEAR THE REAR PANEL OF THIS E360 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129619 ↗
• MalfunctionJul 31, 2018Failure to Deliver; No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE E360 VENTILATOR WAS NOT DELIVERING VOLUME. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: Hypoventilation; No Code Available

  MAUDE report 7736059 ↗
• MalfunctionJun 25, 2018Device Inoperable; No Flow; Device Inoperable; No Flow

  IT WAS REPORTED THAT DURING USE ON PATIENT THE E360 VENTILATOR WAS NOT DELIVERING VENTILATION TO THE PATIENT. PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 7634667 ↗
• MalfunctionAug 23, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN INTERNAL AIR LEAKAGE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR 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 SERVICE PROVIDER (SP) RECONNECTED THE AIR INLET REGULATOR BUT FOUND IT NEEDS TO BE REPLACE. 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 Information; No Patient Involvement

  MAUDE report 6814996 ↗
• MalfunctionAug 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6810223 ↗
• MalfunctionAug 21, 2017Leak/Splash; Leak/Splash

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6809197 ↗
• MalfunctionAug 17, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A FLOW SENSOR ERROR. NO PATIENT INVOLVEMENT WAS REPORTED. 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 PROVIDER (SP) REPLACED THE FLOW SENSOR AND CALIBRATED SUCCESSFULLY. 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 6802551 ↗
• MalfunctionAug 16, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE E360 VENTILATOR WAS SUDDENLY SWITCHED OFF. PATIENT INVOLVEMENT WAS NOT REPORTED. 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 Information

  MAUDE report 6798500 ↗
• MalfunctionAug 3, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE E360 VENTILATOR WAS MAKING A NOISE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. 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 PROVIDER FOUND A LEAKAGE. TO ADDRESS THE ISSUE THE SERVICE PROVIDER CONNECTED THE TUBING AND THE DEVICE PASSED ALL TESTING. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCTS RETURNED TO THE MANUFACTURER FOR INVESTIGATION THE COMPLAINT WILL BE RE-EVALUATED.

  Patient problems: No Patient Involvement

  MAUDE report 6765518 ↗
• MalfunctionJul 28, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING MAINTENANCE THE E360 VENTILATOR HAD FLOW SENSOR ERROR. THE VENTILATOR WAS NOT ON A PATIENT 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 WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE ENGINEER (SE) CHECKED THE VENTILATOR AND PASSED THE LEAK TEST, O2 SENSOR CALIBRATION. PERFORMED FLOW SENSOR CALIBRATION BUT IT WAS SHOWING CALIBRATION ERROR. VENTILATOR IS WORKING FINE BUT FLOW SENSOR NEEDS TO BE REPLACED. 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 Information; No Patient Involvement

  MAUDE report 6750334 ↗
• MalfunctionJul 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN E360 VENTILATOR HAD AN OXYGEN SENSOR ISSUE. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR AND CLEANED THE EXHAUST VALVE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6736571 ↗
• MalfunctionJun 15, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6643223 ↗
• MalfunctionJun 13, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A INTERNAL LEAK. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVI DIEN/MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-COVIDIEN /MEDTRONIC SERVICE PROVIDER CHECKED ALL PARAMETERS OF VENTILATOR, PERFORMED AND PASSED CIRCUIT TEST. PERFORMED AND PASSED FLOW SENSOR CALIBRATION. PERFORMED AND PASSED OXYGEN SENSOR CALIBRATION. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6638852 ↗
• MalfunctionJun 5, 2017Defective Component; Device Displays Incorrect Message; Defective Component; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR BACK UP VENTILATION ALARM BEEPS CONTINUOUSLY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION.

  Patient problems: No Patient Involvement

  MAUDE report 6610602 ↗
• MalfunctionJun 2, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 360 VENTILATOR AIR SUPPLY WAS LOST. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-COVIDIEN SERVICE PROVIDER CHECKED THE VENTILATOR, AND CONFIRMED THE CUSTOMER ISSUE. THE SERVICE PROVIDER TIGHTENED ALL INTERNAL FILTERS, PERFORMED FLOW SENSOR AND OXYGEN SENSOR CALIBRATIONS. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Patient Involvement

  MAUDE report 6608281 ↗
• MalfunctionMay 31, 2017Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE E360 VENTILATOR WAS CONTINUOUSLY ALARMING. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Information

  MAUDE report 6602159 ↗
• MalfunctionMay 31, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT E360 VENTILATOR HAD AN OXYGEN SENSOR ERROR. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Information

  MAUDE report 6602117 ↗
• MalfunctionMay 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING MAINTENANCE THE E360 VENTILATOR HAD AN OXYGEN SENSOR ERROR. THERE WAS NO PATIENT INVOLVEMENT. COVIDIEN WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED.

  Patient problems: No Patient Involvement

  MAUDE report 6598109 ↗
• MalfunctionApr 24, 2017Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THERE WERE NO AIR OR OXYGEN READINGS. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE VENTILATOR WAS EVALUATED BY A NON-MEDTRONIC SERVICE PROVIDER AND THE OXYGEN DELIVERY WAS OUT OF SPECIFICATION. THE OXYGEN SENSOR WAS REPLACED, WHICH RESOLVED THE CONDITION. MEDTRONIC WAS NOT AUTHORIZED TO SERVICE THE VENTILATOR.

  Patient problems: No Information

  MAUDE report 6517360 ↗
• MalfunctionApr 3, 2017Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE E360 VENTILATOR WOULD NOT POWER ON. PATIENT INVOLVEMENT IS UNKNOWN. NON-COVIDIEN/ MEDTRONIC SERVICE PROVIDER INSPECTED THE DEVICE AND FOUND THE BATTERY WILL NEED TO BE REPLACED. COVIDIEN/ MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE.

  Patient problems: No Information

  MAUDE report 6453210 ↗