Newport E360E-SY-INRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10884521540965), received between May 9, 2017 and Apr 18, 2018 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2018Leak/Splash; Leak/Splash

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

  Patient problems: No Patient Involvement

  MAUDE report 7441280 ↗
• MalfunctionOct 20, 2017Sparking; Sparking

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

  Patient problems: No Patient Involvement

  MAUDE report 6965656 ↗
• MalfunctionOct 19, 2017Sparking; Sparking

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD SPARKING PROBLEM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6962631 ↗
• MalfunctionAug 28, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN AIR LEAK IN THE UNIT AND SUPPLY LOSS 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 6825421 ↗
• MalfunctionAug 25, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD CONTINUOUS ALARM SOUND. 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 6822929 ↗
• MalfunctionAug 15, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN AIR WATER TRAP THAT WAS LEAKING. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. 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 6794630 ↗
• MalfunctionAug 14, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TESTING THE E360 VENTILATOR HAD AN INTERNAL 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 WAS COMPLETED AT A NON-MEDTRONIC LOCATION. THE SERVICE PROVIDER OPENED THE VENTILATOR AND FOUND TUBING DISCONNECTED, RECONNECTED ALL THE CONNECTIONS PROPERLY AND THE VENTILATOR WAS FOUND TO BE 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 Patient Involvement

  MAUDE report 6792704 ↗
• MalfunctionAug 1, 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 Patient Involvement

  MAUDE report 6756862 ↗
• MalfunctionJul 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN PROBLEM. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. 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 6752645 ↗
• MalfunctionJul 28, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT E360 VENTILATOR HAD A FLOW SENSOR ERROR ALARM. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. 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 6752622 ↗
• MalfunctionJul 5, 2017Leak/Splash; Leak/Splash

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

  Patient problems: No Information

  MAUDE report 6688018 ↗
• MalfunctionJun 30, 2017Air Leak; Air Leak

  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 6683078 ↗
• MalfunctionJun 29, 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 6677662 ↗
• MalfunctionJun 21, 2017Device Sensing Problem; Device Sensing Problem

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

  Patient problems: No Information

  MAUDE report 6657293 ↗
• MalfunctionJun 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.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6657284 ↗
• MalfunctionJun 14, 2017High Readings; High Readings

  IT WAS REPORTED THAT THE E360 VENTILATOR OXYGEN WAS HIGH. 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; No Patient Involvement

  MAUDE report 6639755 ↗
• MalfunctionJun 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR GENERATED A LEAK. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVIDIEN /MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-COVIDIEN /MEDTRONIC SERVICE PROVIDER TIGHTENED THE FILTERS INSIDE THE VENTILATOR AND THE ISSUE WAS RESOLVED. THE VENTILATOR WORKED NORMALLY.

  Patient problems: No Information

  MAUDE report 6635468 ↗
• MalfunctionJun 9, 2017Battery Problem; Battery Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REPORTED ISSUE OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF EVENT.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6629573 ↗
• MalfunctionJun 8, 2017Leak/Splash; Connection Problem; Leak/Splash; Connection Problem

  IT WAS REPORTED THAT THE 360 VENTILATOR HAD AN OXYGEN LEAK. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. COVIDI EN/MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-COVIDIEN /MEDTRONIC SERVICE PROVIDER RECONNECTED THE TUBES TO THE OXYGEN SENSOR FILTER AND THE ISSUE WAS RESOLVED. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Information

  MAUDE report 6625022 ↗
• MalfunctionJun 5, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE E360 VENTILATOR. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-MEDTRONIC SERVICE PROVIDER CHECKED THE VENTILATOR AND COULD NOT DUPLICATE THE ISSUE. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Information

  MAUDE report 6613676 ↗
• MalfunctionJun 2, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR FLOW SENSOR AND FLOW SENSOR CABLE ARE FAULTY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED CONDITION. A NON- COVIDIEN SERVICE PROVIDER INSPECTED THE DEVICE AND THE CUSTOMER ISSUE WAS CONFIRMED. TO ADDRESS THE REPORTED ISSUE, THE FLOW SENSOR AND FLOW SENSOR CABLE WERE REPLACED. THE VENTILATOR WAS TESTED AND CHECKED TO BE RUNNING NORMALLY.

  Patient problems: No Patient Involvement

  MAUDE report 6608329 ↗
• MalfunctionJun 2, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE E360 VENTILATOR DISPLAY WAS BLANK. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. A THIRD PARTY SERVICE PROVIDER CHECKED THAT ALL CONNECTIONS WERE CONNECTED PROPERLY. THE VENTILATOR WAS TESTED AND REPORTED TO BE RUNNING NORMALLY.

  Patient problems: No Information

  MAUDE report 6607741 ↗
• MalfunctionJun 1, 2017Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE E360 VENTILATOR OXYGEN SUPPLY WAS LOST AND HAD LEAKING NOISE. PATIENT INVOLVEMENT IS UNKNOWN. MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/SERVICE THE DEVICE SO THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. A NON-MEDTRONIC SERVICE PROVIDER CHECKED THE VENTILATOR AND VERIFIED THE PROBLEM.

  Patient problems: No Information

  MAUDE report 6603921 ↗
• MalfunctionMay 9, 2017Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A E360 VENTILATOR WOULD NOT TURN ON. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER.

  Patient problems: No Information

  MAUDE report 6553707 ↗