Newport E360T-SY-IN (UDI 10884521541283)Recalls & reported problems

Summary

The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 10884521541283), received between Apr 17, 2017 and Jan 14, 2025 — classified as 107 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (26 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Smoking; Pressure Problem; Smoking; Pressure Problem

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE EKOM C235 COMPRESSOR OF THIS E360 VENTILATOR HAD AN ISSUE. 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 21152905 ↗
• MalfunctionMay 5, 2023Smoking; Smoking

  IT WAS REPORTED THAT THE COMPRESSOR USED ON THIS E360 VENTILATOR WAS ¿BURNING FROM THE INSIDE¿. 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 16880951 ↗
• MalfunctionOct 21, 2022Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE E360 VENTILATOR DELIVERED A HIGH TIDAL VOLUME AND THE UNIT DID NOT ALARM. 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 15651669 ↗
• MalfunctionOct 28, 2021Smoking; Smoking

  IT WAS REPORTED THAT SMOKE WAS OBSERVED FROM THIS E360 VENTILATOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711830 ↗
• MalfunctionSep 24, 2021Smoking; Smoking

  IT WAS REPORTED THAT SMOKE WAS OBSERVED COMING FROM THE 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 12526541 ↗
• MalfunctionJun 22, 2020Smoking; Smoking

  IT WAS REPORTED THAT THERE WAS A SMOKE COMING FROM THE E360 VENTILATOR COMPRESSOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10179439 ↗
• MalfunctionNov 8, 2019Smoking; Smoking

  IT WAS REPORTED THAT THIS E360 VENTILATOR HAD SMOKE COMING FROM THE COMPRESSOR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9297416 ↗
• MalfunctionMar 13, 2019Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING SERVICING, THE E360 VENTILATOR FAILED CALIBRATION AND FOUND THE DEVICE HAD NO AUDIBLE ALARM WITH THE FAULTY LOUDSPEAKERS. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8418713 ↗
• MalfunctionNov 1, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE E360 VENTILATOR WAS NOT DELIVERING TIDAL VOLUME. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Code Available

  MAUDE report 8031222 ↗
• MalfunctionSep 21, 2018Smoking; Smoking

  IT WAS REPORTED THAT, WHILE IN STANDBY MODE, THE E360 VENTILATOR WAS FOUND BURNT. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7899642 ↗
• MalfunctionJun 21, 2018Thermal Decomposition of Device; Mechanical Problem; Thermal Decomposition of Device; Mechanical Problem

  IT WAS REPORTED THAT THE COMPRESSOR WAS NOT WORKING. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO ADVERSE EVENT OR CONSEQUENCES AS A RESULT.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 7626646 ↗
• MalfunctionApr 17, 2018Sparking; Sparking

  IT WAS REPORTED THAT THE E360 VENTILATOR WAS SPARKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7436323 ↗
• MalfunctionMar 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN OXYGEN TO THE E360 VENTILATOR WAS PROVIDED, THE UNIT IS LEAKED AIR AT INLET WATER TRAP INSIDE INLET OXYGEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7383478 ↗
• MalfunctionMar 29, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN OXYGEN TO THE E360 VENTILATOR WAS PROVIDED, THE UNIT IS LEAKED AIR AT INLET WATER TRAP INSIDE INLET OXYGEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7383409 ↗
• MalfunctionFeb 12, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE E360 VENTILATOR FUSE WAS BLOWN. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7265304 ↗
• MalfunctionSep 6, 2017Device Inoperable; Device Inoperable

  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 6845522 ↗
• MalfunctionAug 25, 2017Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN E360 VENTILATOR HAD OXYGEN (O2) 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 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 6822934 ↗
• MalfunctionAug 25, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AN E360 VENTILATOR HAD A LEAK. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) CHECKED THE EXHALATION VALVE SYSTEM AND FOUND IT DIRTY. THE SE CHANGED EXHALATION VALVE AND THE UNIT PASSED ALL TESTS AND CALIBRATIONS. THE UNIT OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6822761 ↗
• MalfunctionAug 24, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN E360 VENTILATOR HAD A FLOW SENSOR ERROR. 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 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 6818908 ↗
• MalfunctionAug 24, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD NO OXYGEN (O2) SUPPLY IN THE UNIT. 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 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 6817688 ↗
• MalfunctionAug 23, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR WAS DISPLAYING LOW FRACTION OF INSPIRED OXYGEN (FIO2) ALARM. 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 PROVIDER (SP) FOUND O2 % DISPLAYED IS TOO LOW AS COMPARED TO THE SET VALUE. THE SP PERFORMED O2 SENSOR CALIBRATION AND PASSED IT. THE UNIT IS IN WORKING CONDITION. 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 6814842 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR FAILED THE FLOW SENSOR CALIBRATION (AUDIBLE AND VISUAL ALARM WAS FOUND ON THE SCREEN). 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 PROVIDER (SP) REPLACED THE FLOW SENSOR. THE SP PERFORMED CALIBRATIONS AND THE DEVICE WORKS SATISFACTORILY NOW. 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 6809178 ↗
• MalfunctionAug 21, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A LOW FRACTION OF INSPIRED OXYGEN (FIO2) ALARM. 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 PROVIDER (SP) FOUND THAT THE O2 % DISPLAYING WAS TOO LOW AS COMPARED TO THE SET VALUE THE SP PERFORMED O2 SENSOR CALIBRATION AND THE UNIT PASSED IT. THE DEVICE WORKS SATISFACTORILY NOW . 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 6809069 ↗
• MalfunctionAug 21, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE PROVIDER REPLACED THE FLOW SENSOR AND THE ISSUE WAS RESOLVED. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6808083 ↗
• MalfunctionAug 21, 2017Failure to Calibrate; Device Displays Incorrect Message; Failure to Calibrate; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR FAILED FLOW SENSOR CALIBRATION (AUDIBLE AND VISUAL ALARM WAS FOUND ON THE SCREEN). 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 PROVIDER (SP) REPLACED THE FLOW SENSOR. THE VENTILATOR WAS CALIBRATED AND WORKS SATISFACTORILY NOW. 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 6808001 ↗