Trilogy Evo ND2110X15BRecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00606959055513), received between Apr 20, 2022 and Apr 17, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (12 reports).

4 FDA recall records name this device's identifier, 4 still open.

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.

Recalls naming this device

1. Oct 7, 2024Open, Classified

   Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.

   Z-0291-2025 · Root cause: Device Design · FDA record ↗

2. Jul 16, 2024Open, Classified

   Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

   Z-2944-2024 · Root cause: Device Design · FDA record ↗

3. Mar 19, 2024Open, Classified

   Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.

   Z-1504-2024 · Root cause: Device Design · FDA record ↗

4. Nov 27, 2023Open, Classified

   The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

   Z-0638-2024 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR HAD A RED, CRITICAL ALARM TRIGGERED WHILE IN USE WITH A PATIENT. THERE WAS NO HARM OR INJURY REPORTED. IT WAS REPORTED THE ALARM STATED "VENTILATOR SERVICE REQUIRED" OCCURRED ON THE DEVICE ON 11 MARCH 2026. NO ADDITIONAL INFORMATION HAS PROVIDED AT THIS TIME. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915710 ↗
• MalfunctionMar 30, 2026Circuit Failure; Electrical /Electronic Property Problem; Power Problem

  THE MANUFACTURER RECEIVED INFORMATION THAT A TRILOGY EVO VENTILATOR HAD A RED, CRITICAL ALARM TRIGGERED WHILE IN USE WITH A PATIENT. THERE WAS NO HARM OR INJURY REPORTED. IT WAS REPORTED THE ALARM THAT INDICATED "VENTILATOR SERVICE REQUIRED" OCCURRED ON THE DEVICE ON 11 MARCH 2026. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730477 ↗
• MalfunctionDec 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE SCREEN ON THE TRILOGY EVO, NORDICS DEVICE IS COMPLETELY RED AND THE ALARM SOUNDS VERY LOUDLY. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO, NORDICS DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934583 ↗
• MalfunctionDec 31, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE TRILOGY EVO, NORDICS DEVICE WON'T START, JUST A RED SCREEN, CONSTANT WHINING AND A TEXT BOX THAT SAYS, "VENTILATOR NOT WORKING". THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE TRILOGY EVO, NORDICS DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934581 ↗
• MalfunctionDec 22, 2025Contamination; Gas Output Problem; Device Sensing Problem; Contamination; Gas Output Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO VENTILATE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. A PRELIMINARY EVALUATION WAS PERFORMED. THE DEVICE'S MACHINE FLOW SENSOR AND BLOWER WERE FOUND TO BE CONTAMINATED WITH DUST. THE EVALUATION HAS NOT YET BEEN COMPLETED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863993 ↗
• MalfunctionDec 8, 2025Electrical /Electronic Property Problem; Failure to Calibrate; Electrical /Electronic Property Problem; Failure to Calibrate

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR FAILED TESTING FOR SYSTEM LEAK VERIFICATION: PRESSURE DROP OVER 10S. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM OR INJURY REPORTED. DEPENDING ON WHERE THE LEAK IS, IT COULD CAUSE A NUMBER OF VARIOUS ISSUES RELATED TO CONTROL AND MEASUREMENT ACCURACY. THE DEVICE HAS NOT YET BEEN RETURNED. THEREFORE, DEVICE EVALUATION FOR THE REPORTED ISSUE HAS NOT YET BEEN COMPLETED. AT THIS TIME, THE MANUFACTURER IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741525 ↗
• MalfunctionNov 5, 2025Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  A TRILOGY EVO, NORDICS VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE TRILOGY EVO, NORDICS DEVICE AT THIRD-PARTY SERVICE CENTER, AN EVT_INTERNAL_BATT_NOT_DETECTED ERROR WAS OBSERVED IN THE DEVICE'S EVENT LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. ADDITIONALLY, THE BLOWER ASSEMBLY, BELLOW BLOWER, MACHINE FLOW SENSOR, AND IN-LINE FILTER PROX. ARE CONTAMINATED AND NEEDED TO BE REPLACED. THE AIR FOAM INLET FILTER, MUFFLER ASSEMBLY, AND PARTICULATE FILTER WERE REPLACED DUE TO PREVENTIVE MAINTENANCE. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, AND MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23479645 ↗
• MalfunctionSep 17, 2025Battery Problem; Battery Problem

  THE TRILOGY EVO VENTILATOR WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR COMPLETION OF PREVENTATIVE MAINTENANCE. DURING THE EVALUATION IT WAS NOTED THAT THE DETACHABLE BATTERY AND THE INTERNAL BATTERY WERE MISSING FROM THE DEVICE. A VENTILATOR SERVICE REQUIRED ALARM ERROR CODE E-46 APPEARED SEVERAL TIMES IN THE DEVICE ERROR LOG INDICATING THE INTERNAL BATTERY COULD BE DETECTED. BASED ON ERROR CODE E-46, THE INTERNAL BATTERY WAS REPLACED. ADDITIONAL FINDINGS NOT RELATED TO THE MALFUNCTION/ISSUE: THE DETACHABLE BATTERY HARNESS WAS DEFECTIVE REQUIRING REPLACEMENT. THE AIR FOAM INLET FILTER WILL BE REPLACED DUE TO PREVENTIVE MAINTENANCE. THE IN-LINE PROXIMAL FILTER WAS CONTAMINATED AND REQUIRED REPLACEMENT. THE VANITY COVER HAD COSMETIC DAMAGE AND REQUIRED REPLACEMENT. THIS DEVICE HAS BEEN SERVICED, INSPECTED, TESTED, MET ACCEPTANCE CRITERIA IN ACCORDANCE WITH ALL OF THE APPLICABLE CUSTOMER REQUIREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071756 ↗
• MalfunctionJul 7, 2025Failure to Power Up; Failure to Power Up

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO DEVICE FAILED TO POWER ON AND WAS ALARMING FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414474 ↗
• MalfunctionJul 7, 2025Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED TO CHARGE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22414459 ↗
• MalfunctionApr 30, 2025Charging Problem; Charging Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR PREVENTIVE MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION A SERVICE REQUIRED ALARM CONDITION INDICATING THE INTERNAL BATTERY FAILED TO CHARGE WAS OBSERVED IN THE DOWNLOADED EVENT LOG. THE SERVICE CENTER WAS UNABLE TO DUPLICATE THE ALARM. THE DEVICE WAS TESTED WITH A GOLD BATTERY AND PASSED ALL TESTING. NO COMPONENT WAS REPLACED TO ADDRESS THIS ISSUE. ADDITIONALLY, THE INTERNAL BATTERY DOOR WAS DAMAGED, AND THE USB COVER WAS MISSING. THE COMPONENTS WERE REPLACED. THE AIR FOAM INLET FILTER, MUFFLER AND PARTICULATE FILTER WERE REPLACED PER PREVENTIVE MAINTENANCE PROTOCOL. THE DEVICE WAS TESTED AND PASSED ALL FINAL TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21933842 ↗
• MalfunctionOct 4, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR DOES NOT POWER ON BUT HAS A NOT OPERATIVE CONDITION MESSAGE ON A RED DISPLAY SCREEN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20370410 ↗
• MalfunctionAug 21, 2024Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ACTIVE EXHALATION VALVE ERROR HAD OCCURRED ON THE DEVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013265 ↗
• MalfunctionMay 21, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DAMAGED LIQUID CRYSTAL DISPLAY SCREEN HAD OCCURRED ON THE DEVICE. THEY ALLEGED THE DAMAGE IS VISIBLE WHEN STARTING THE VENTILATOR AND NO TEXT CAN BE READ. THEY ALLEGED HARM BUT DID NOT SPECIFY THE TYPE OF HARM. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 19367093 ↗
• MalfunctionMay 7, 2024Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S ACTIVE EXHALATION VALVE NOT WORKING. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260457 ↗
• MalfunctionApr 25, 2024Electrical /Electronic Property Problem; Device Sensing Problem; Electrical /Electronic Property Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182169 ↗
• MalfunctionFeb 12, 2024Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY EVO VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, ERROR CODES E-144 AND E-262 WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM PCA AND BLOWER WAS REPLACED TO ADDRESS THE ISSUE. IN ADDITION, THE AIR INLET FILTER FOAM WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18684072 ↗
• MalfunctionFeb 2, 2024Circuit Failure; Mechanical Problem; Circuit Failure; Mechanical Problem

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A "VENT INOPERATIVE" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BUZZER ASSEMBLY, SENSOR BOARD AND MUFFLER ASSEMBLY WERE REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635732 ↗
• MalfunctionDec 8, 2023Circuit Failure; Electrical /Electronic Property Problem; Circuit Failure; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM SOUNDED. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. THE DEVICE IS CURRENTLY WAITING FOR ESTIMATE APPROVAL TO REPLACED THE INTERNAL BATTERY, MUFFLER ASSEMBLY, MACHINE FLOW SENSOR, AIR INLET FOAM, SYSTEM PC BOARD ASSEMBLY, BLOWER ASSEMBLY, AND BUZZER ASSEMBLY. ONCE APPROVAL IS GRANTED THE PARTS WILL BE REPLACED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION AND/OR REPAIRS ARE COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290889 ↗
• MalfunctionNov 27, 2023Mechanical Problem; Pressure Problem; Mechanical Problem; Pressure Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN "AEV FAILURE" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18208513 ↗
• MalfunctionOct 12, 2023Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE VENTILATOR DISPLAYED A RED SCREEN AND WAS PRODUCING A LOUD ALARM. THE DEVICE WAS NOT IN USE ON A PATIENT DURING THE ALLEGED OCCURRENCE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17928175 ↗
• MalfunctionOct 11, 2023Failure to Charge; Failure to Charge

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR SERVICE REQUIRED ALARM OCCURRED RELATED TO BATTERY WAS NOT CHARGING FAULT. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912755 ↗
• MalfunctionSep 27, 2023Battery Problem; Charging Problem; Battery Problem; Charging Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR¿S BATTERY AND CHARGING SYSTEM WERE DEFECTIVE. THE DEVICE WAS NOT IN PATIENT USE. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824484 ↗
• MalfunctionSep 1, 2023Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING CIRCUIT BREAKER FOR CIRCUIT FAILURE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669837 ↗
• MalfunctionAug 3, 2023Contamination; Improper Flow or Infusion; Contamination; Improper Flow or Infusion

  A VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, IT WAS OBSERVED THAT THE DEVICE'S FLOW WAS DECREASE. THE DEVICE'S MACHINE FLOW SENSOR NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THERE WAS EVIDENCE OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17449996 ↗