Newport E360T-SY-IN (UDI 10884521510807)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521510807), received between Jun 5, 2017 and Sep 3, 2021 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (13 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2021Smoking; Smoking

  IT WAS REPORTED THAT SMOKE WAS SEEN FROM THE E360 VENTILATOR'S COMPRESSOR CAPACITOR AND THE COMPRESSOR WAS NOT WORKING. 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 12421304 ↗
• MalfunctionAug 25, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN E360 VENTILATOR HAD A CONTINUOUS FLOW SENSOR ERROR ALARM (AUDIBLE AND VISUAL). 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. A THIRD PARTY SERVICE PROVIDER FOUND THE REPORTED ISSUE. THE FLOW SENSOR WAS REPLACED TO RESOLVE THE ISSUE. 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 6822940 ↗
• MalfunctionAug 24, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE 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 6817498 ↗
• MalfunctionAug 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN (O2) LEAKAGE. 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 THE LEAKAGE INSIDE THE VENTILATOR, OPENING UP THE VENTILATOR FOUND THE TUBING DISCONNECTED. THE SP TIGHTENED ALL THE CONNECTION AND RESOLVED THE ISSUE. 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 6809142 ↗
• MalfunctionAug 21, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN (O2) LEAKAGE. 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 THE LEAKAGE INSIDE THE VENTILATOR, OPENING UP THE VENTILATOR FOUND THE TUBING DISCONNECTED. THE SE TIGHTENED ALL THE CONNECTION AND RESOLVED THE ISSUE. 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 6809114 ↗
• MalfunctionAug 17, 2017Leak/Splash; Leak/Splash

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE REPAIR WAS COMPLETED AT A NON-COVIDIEN/MEDTRONIC LOCATION. A NON-COVIDIEN /MEDTRONIC SERVICE PROVIDER REPLACED THE COMPRESSOR SO LENOID, BUT REPORTED WATER TRAP NEEDS TO BE REPLACED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6802417 ↗
• MalfunctionAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD LOW FRACTION OF INSPIRED OXYGEN (FIO2). 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

  MAUDE report 6799190 ↗
• MalfunctionAug 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A LOW FRACTION OF INSPIRED OXYGEN (FIO2). 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 6799124 ↗
• MalfunctionAug 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING TESTING THE E360 VENTILATOR HAD A FLOW SENSOR ERROR. 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 EXHALATION FLOW SENSOR. 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 6798342 ↗
• MalfunctionAug 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE E360 VENTILATOR LOST THE OXYGEN (O2) SUPPLY. 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 6792644 ↗
• MalfunctionAug 14, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING TESTING THE E360 VENTILATOR HAD A FLOW SENSOR ERROR. 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 A LEAKAGE FROM OXYGEN (O2). THE SP CONNECTED THE CONNECTIONS, PERFORMED FLOW SENSOR AND O2 SENSOR CALIBRATION SUCCESSFULLY. THE UNIT OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS. 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 6792208 ↗
• MalfunctionAug 11, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE E360 VENTILATOR SCREEN WAS NOT WORKING. 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. THE SERVICE PROVIDER (SP) CLEANED THE VENTILATOR AND SUCCESSFULLY PASSED ALL TESTS. 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 6789246 ↗
• MalfunctionAug 11, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD NO OXYGEN (O2) SUPPLY. 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 6789141 ↗
• MalfunctionAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SERVICE OF AN E360 VENTILATOR, THE OXYGEN (O2) SENSOR WAS FOUND TO BE FAULTY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. COVIDIEN/MEDTRONIC WAS NOT AUTHORIZED TO EVALUATE/REPAIR THE DEVICE AS THE PRODUCT IS NOT IN COVIDIEN/MEDTRONIC CONTROL. A THIRD PARTY SERVICE PROVIDER REPORTED THAT THE O2 SENSOR NEEDED 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 Patient Involvement

  MAUDE report 6786373 ↗
• MalfunctionAug 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A SETTING ISSUE. 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 6785838 ↗
• MalfunctionAug 9, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD A OXYGEN SENSOR ALARM. THERE WAS NO PATIENT INVOLVEMENT. 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 6778369 ↗
• MalfunctionAug 9, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN SENSOR ALARM. THERE WAS NO PATIENT INVOLVEMENT. 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 O2 SENSOR, PERFORMED CALIBRATION AND THE VENTILATOR 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 6778315 ↗
• MalfunctionAug 9, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN SENSOR ALARM. THERE WAS NO PATIENT INVOLVEMENT. 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 O2 SENSOR AND CALIBRATED IT SUCCESSFULLY. THE VENTILATOR 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 6778208 ↗
• MalfunctionAug 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE PROVIDER REPLACED THE EXHALATION FLOW SENSOR AND PERFORMED FLOW SENSOR CALIBRATION SUCCESSFULLY. THE SERVICE PROVIDER CHECKED AND VERIFIED ALL THE FUNCTIONS PER MANUFACTURER'S SPECIFICATIONS AND THE VENTILATOR IS WORKING CONDITION.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6772284 ↗
• MalfunctionAug 7, 2017Failure to Calibrate; Failure to Calibrate

  THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A NON-MEDTRONIC SERVICE PROVIDER (SP) INSPECTED THE DEVICE AND FOUND THE OXYGEN SENSOR TO BE FAULTY. THE SP REPLACED THE OXYGEN SENSOR TO RESOLVE THE ISSUE.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6771158 ↗
• MalfunctionAug 4, 2017No Pressure; No Pressure

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD AN OXYGEN (O2) LOSS. 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

  MAUDE report 6768240 ↗
• MalfunctionAug 4, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT THE E360 VENTILATOR SHUT DOWN. 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 SERVICE PROVIDER FOUND THE BATTERY NEEDS TO BE REPLACED. 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 6767893 ↗
• MalfunctionAug 2, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT E360 VENTILATOR HAD A LEAK. 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 WAS COMPLETED AT A NON-MEDTRONIC LOCATION AND THE SERVICE PROVIDER FOUND A LEAKAGE IN THE TUBING. THE SERVICE PROVIDER CONNECTED THE TUBING PROPERLY AND PERFORMED CALIBRATIONS. 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 6760274 ↗
• MalfunctionAug 1, 2017Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE E360 VENTILATOR COMPRESSOR WAS MAKING NOISE. 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

  MAUDE report 6757994 ↗
• MalfunctionAug 1, 2017High Readings; High Readings

  IT WAS REPORTED THAT THE E360 VENTILATOR HAD HIGH FRACTION OF INSPIRED OXYGEN (FIO2) READINGS. 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

  MAUDE report 6757002 ↗