Sensor External Flow Sensor, Adult/PedRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00606959050839), received between Jul 9, 2021 and Feb 22, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 22, 2023Contamination; Mechanical Problem; Contamination; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S EXTERNAL FLOW SENSOR FAILED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THERE WAS EVIDENCE OF CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16416068 ↗
• MalfunctionDec 21, 2021Device Sensing Problem; Device Sensing Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A FLOW SENSOR ERROR. THERE WAS NO HARM OR INJURY REPORTED. THE EXTERNAL FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE EXTERNAL FLOW SENSOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE EXTERNAL FLOW SENSOR WAS CONTAMINATED WITH DUST AND DIRT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13054094 ↗
• MalfunctionDec 21, 2021Contamination; Contamination

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A FAULTY FLOW SENSOR. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE'S EXTERNAL FLOW SENSOR WAS REPLACED TO ADDRESS THE ISSUE. THE FLOW SENSOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE EXTERNAL FLOW SENSOR WAS FOUND TO HAVE RUST ON THE INTERNAL MESH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053349 ↗
• MalfunctionJul 9, 2021Tidal Volume Fluctuations; Tidal Volume Fluctuations

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A MALFUNCTION OF A VENTILATOR'S EXTERNAL FLOW SENSOR CAUSING DECREASED TIDAL VOLUMES. THERE WAS NO HARM OR INJURY REPORTED. THE COMPONENT 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 12141864 ↗