eVolution 3e Ventilator eVolution 3e Ventilator- Turbine EssentialRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00860008873606), received between Oct 28, 2022 and Mar 10, 2026 — classified as 1 death, 26 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (23 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• DeathMar 10, 2026Insufficient Device Problem Information

  ON FEBRUARY 10, 2026, EVENT MEDICAL RECEIVED AN EMAIL NOTIFICATION FROM ITS DISTRIBUTOR ZEUS MEDICA, LOCATED IN ALGERIA, REPORTING TWO PATIENT DEATHS ALLEGEDLY OCCURRING WHILE PATIENTS WERE RECEIVING THERAPY WITH EVENT MEDICAL EVOLUTION 3E VENTILATORS, MODEL: EVL100000-HP-NF, SERIAL NUMBERS:(B)(6) AND LATER ON FEB 19TH , DISTRIBUTOR CHANGED THE SERIAL NUMBERS TO (B)(6). THE NOTIFICATION WAS RECEIVED SOLELY VIA EMAIL FROM THE DISTRIBUTOR. NO FORMAL COMPLAINT REPORT, SERVICE REPORT, OR OTHER OFFICIAL DOCUMENTATION WAS PROVIDED WITH THE NOTIFICATION. TO DATE, EVENT MEDICAL HAS NOT RECEIVED ANY DIRECT COMMUNICATION FROM THE HOSPITAL WHERE THE EVENTS ALLEGEDLY OCCURRED. UPON RECEIPT OF THE DISTRIBUTOR'S EMAIL, EVENT MEDICAL INITIATED ITS COMPLAINT HANDLING AND INVESTIGATION PROCESS AND REQUESTED DETAILED INFORMATION FROM THE DISTRIBUTOR TO ALLOW EVALUATION OF THE REPORTED EVENTS. FORMAL REQUESTS FOR SUPPORTING DOCUMENTATION AND DEVICE DATA WERE SENT TO THE DISTRIBUTOR ON FEBRUARY 10TH, FEBRUARY 11TH , FEBRUARY 12TH , FEBRUARY 17TH, MEETING WITH DEALER TECHNICIAN ON FEBRUARY 24TH 2026. THE REQUESTED INFORMATION INCLUDED, BUT WAS NOT LIMITED TO: COMPLETED SERVICE FORMS, ADDITIONAL INFORMA

  Patient problems: Insufficient Information

  MAUDE report 24563838 ↗
• MalfunctionOct 11, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17914747 ↗
• MalfunctionOct 11, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17914660 ↗
• MalfunctionOct 11, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17914585 ↗
• MalfunctionOct 11, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17914447 ↗
• MalfunctionAug 15, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17550896 ↗
• MalfunctionJul 12, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17312676 ↗
• MalfunctionJul 12, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17312656 ↗
• MalfunctionJun 23, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR DRING CALIBRATION . THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17194826 ↗
• MalfunctionMay 31, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR DRING CALIBRATION . THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17033591 ↗
• MalfunctionMay 31, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE OXYGEN (O2) SENSOR CALIBRATION AND THE OXYGEN (O2) HIGH PRESSURE ZERO OFFSET FAILED ON EVOLUTION VENTILATOR . THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17033548 ↗
• MalfunctionApr 11, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16716716 ↗
• MalfunctionApr 4, 2023Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event

  THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED VENTILATOR DISPLAYED THE BLOWER FAULT ALARM WHILE VENTILATING ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON MANUAL VENTILATION WITH NO HARM REPORTED. SERVICE INSPECTED THE VENTILATOR AND NOTICED THAT THE DEVICE BLOWER WAS DAMAGED. THE BLOWER WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679006 ↗
• MalfunctionApr 3, 2023Use of Incorrect Control/Treatment Settings; No Apparent Adverse Event; Use of Incorrect Control/Treatment Settings; No Apparent Adverse Event

  THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT THE EVOLUTION VENTILATOR DISPLAYED A TREMBLE WAVEFORM DURING EXHALATION WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM. THE CUSTOMER REPORTED THAT THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS PER MANUFACTURER SPECIFICATIONS PRIOR TO USE ON THE PATIENT. CUSTOMER USED A TEST LONG TO REPRODUCE THE WAVEFORM TREMBLE ISSUE ON THE UNIT AND REPORTED THAT RAPID BREATHING AND PRESSING THE TEST LUNG WHEN PEAK ALARM IS ACTIVE MAY CAUSE THE TREMBLE ISSUE. CUSTOMER ALSO REPORTED THAT IF THE USER DOES NOT LOCK THE EXHALATION VALVE ASSEMBLY PROPERLY, THE EXHALATION VALVE CAN MOVE WHEN THE PATIENT OR THE TEST LUNG IS BEING VENTILATED. CUSTOMER NOTICED THAT THE SHAFT OF THE EXHALATION VALVE WAS SLIGHTLY BENT. CUSTOMER REPLACED THE VALVE AND REPORTED THAT THE NEW VALVE DID NOT CAUSE THE TREMBLE WAVEFORM ISSUE HOWEVER THE TREMBLE WAVEFORM ISSUE HAPPENED WHEN PRESSING THE TEST LUNG WITH PEAK ALARM BEING ACTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670183 ↗
• MalfunctionApr 3, 2023Use of Incorrect Control/Treatment Settings; No Apparent Adverse Event; Use of Incorrect Control/Treatment Settings; No Apparent Adverse Event

  THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT THE EVOLUTION VENTILATOR DISPLAYED A TREMBLE WAVEFORM DURING EXHALATION WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM. THE CUSTOMER REPORTED THAT THE VENTILATOR PASSED ALL TESTS AND CALIBRATIONS PER MANUFACTURER SPECIFICATIONS PRIOR TO USE ON THE PATIENT. CUSTOMER USED A TEST LONG TO REPRODUCE THE WAVEFORM TREMBLE ISSUE ON THE UNIT AND REPORTED THAT RAPID BREATHING AND PRESSING THE TEST LUNG WHEN PEAK ALARM IS ACTIVE MAY CAUSE THE TREMBLE ISSUE. CUSTOMER ALSO REPORTED THAT IF THE USER DOES NOT LOCK THE EXHALATION VALVE ASSEMBLY PROPERLY, THE EXHALATION VALVE CAN MOVE WHEN THE PATIENT OR THE TEST LUNG IS BEING VENTILATED. THERE WAS NO NEED TO CHANGE THE EXHALATION VALVE AND SERVICE WAS ABLE TO CALIBRATE THE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670158 ↗
• MalfunctionMar 23, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16601563 ↗
• MalfunctionMar 10, 2023Circuit Failure; Circuit Failure

  THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16527133 ↗
• MalfunctionMar 10, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16527127 ↗
• MalfunctionJan 26, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16250710 ↗
• MalfunctionJan 26, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY S PECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16250651 ↗
• MalfunctionJan 25, 2023Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16244833 ↗
• MalfunctionDec 14, 2022Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM/SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15981987 ↗
• MalfunctionDec 1, 2022Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED AN OXYGEN SUPPLY ALARM AND CALIBRATE SENSOR OFFSETS ERROR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S SYSTEM INTERFACE BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY S SPECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15899714 ↗
• MalfunctionNov 8, 2022Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED NO OXYGEN SUPPLY ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S OXYGEN PRESSURE SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY S PECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 15756466 ↗
• MalfunctionNov 8, 2022Circuit Failure; Circuit Failure

  EVENT DESCRIPTION: THE INITIAL REPORTER LOCATED OUTSIDE THE U.S. REPORTED THAT WHILE IN USE ON A PATIENT, THE EVOLUTION VENTILATOR GENERATED LOW OXYGEN SUPPLY ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED. MANUFACTURER NARRATIVE: PATIENT INFORMATION WAS NOT PROVIDED. THE THIRD PARTY SERVICE PERSONNEL (SP) INSPECTED THE VENTILATOR AND CONFIRMED THE REPORTED ISSUE. SP REPLACED THE DEVICE'S OXYGEN PRESSURE SENSOR BOARD TO ADDRESS THE ISSUE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT HAS MET ALL EVENT MEDICAL QUALITY S PECIFICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. EVENT MEDICAL WILL SUBMIT A SUPPLEMENTAL IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 15756232 ↗