3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) 768901Recalls & reported problems

Summary

The FDA's MAUDE database contains 587 adverse event reports that list this exact device (DI 10846446003079), received between May 28, 2015 and Jul 1, 2025 — classified as 4 deaths, 98 injuries, 485 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (404 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 587 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2025Pressure Problem; Pressure Problem

  COMPLAINANT ALLEGED THAT THE VENTILATOR WAS EXPERIENCING FLUCTUATIONS IN MEAN AIRWAY PRESSURE. THE CUSTOMER REPORTED THAT THE CIRCUIT HAD BEEN CHANGED THREE TIMES AND THE OSCILLATOR HAD BEEN REPLACED TWICE. SUBSEQUENTLY, THE ISSUE WAS TEMPORARILY RESOLVED BEFORE THE PROBLEM REAPPEARED. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT HARM DURING THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22377521 ↗
• MalfunctionJun 18, 2025Intermittent Loss of Power; Intermittent Loss of Power

  COMPLAINANT ALLEGED THAT DURING USE, THE DEVICE WAS INTERMITTENTLY LOSING POWER. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283148 ↗
• MalfunctionMay 20, 2025No Device Output; No Device Output

  COMPLAINANT ALLEGED THAT DURING USAGE, THE DEVICE ALARMED AND THE OSCILLATOR STOPPED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056056 ↗
• MalfunctionMay 20, 2025Pressure Problem; Pressure Problem

  COMPLAINANT ALLEGED THAT DURING USAGE, THE DEVICE'S MEAN AIRWAY PRESSURE WAS FLUCTUATING. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056027 ↗
• MalfunctionMay 20, 2025Activation Problem; Activation Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE START AND STOP BUTTON INTERMITTENTLY NOT STOPPING THE DRIVER WHEN PRESSED. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055997 ↗
• MalfunctionMay 12, 2025Pressure Problem; Pressure Problem

  COMPLAINANT ALLEGED THAT WHILE REMOVING PATIENT FROM THE DEVICE AND REATTACHING THE PATIENT, THE UNIT FAILED TO REPRESSURIZE AND THE USER HAD TO PRESS THE RESET AND POWER BUTTON SEVERAL TIMES. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22004874 ↗
• MalfunctionJan 28, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE 3100A VENT STOPPED OSCILLATING WHILE ON PATIENT. THE UNIT WAS SWAPPED OUT TO COMPLETE THE PROCEDURE. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251477 ↗
• MalfunctionJul 23, 2024Delayed Alarm; Delayed Alarm

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR ALARM BOARD IS NOT WORKING PROPERLY. IT ALARMS AT THE INCORRECT READING. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19812094 ↗
• MalfunctionJun 18, 2024Noise, Audible; Noise, Audible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS A LOUD LEAKING NOISE COMING FROM THE DRIVER COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558819 ↗
• InjuryJun 17, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CUSTOMER WAS HAVING ISSUES WITH THE MAP ALARM. THE INITIAL ISSUE OCCURRED ON (B)(6) 2024 AND THE DEVICE HAD BEEN ON THE PATIENT FOR 3 DAYS AT THAT POINT. WHEN IT ALARMED, THEY NOTICED THE MAP AT -6.0 AND THE FREQUENCY AT 1.6. THEY MOVED THE PATIENT TO A DIFFERENT VENTILATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19552572 ↗
• MalfunctionMay 24, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A UNIT HAS ISSUES WITH A FLUCTUATING FREQUENCY.WHEN THEY TRY TO SET THE FREQUENCY TO 14 IT WILL JUMP TO 5 OR 6 AND FLUCTUATE. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19393396 ↗
• MalfunctionMay 24, 2024Failure to Recalibrate; Failure to Recalibrate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAS MAP (MEAN AIRWAY PRESSURE) IS READING 13CMH20. SYSTEM IS NOT PRESSURIZED, STOPPER IS NOT IN THE CIRCUIT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392129 ↗
• MalfunctionMay 21, 2024Failure to Recalibrate; Failure to Recalibrate

  IT WAS REPORTED TO THE VYAIRE MEDICAL THAT THE 3100A DOES NOT PRESSURIZE. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359139 ↗
• MalfunctionMay 15, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED TO VYAIRE MEDICAL THE 3100A VENTILATOR NEEDS AN FST (FIELD SERVICE TECHNICIAN) TO EVALUATE. THERE WAS CONCERN OF THE PISTON NOT CENTERING WHILE AT THE SETTINGS THEY NEEDED, BUT SWITCHED THE UNIT WITH A 3100B AND THE SETTINGS WERE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322879 ↗
• InjuryMay 13, 2024High Readings; High Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENT AMPS WAS READING 004 ON A PATIENT. FURTHERMORE, THE WATER BAG ON TOP OF UNIT WAS LEAKING. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305692 ↗
• InjuryMay 6, 2024High Readings; High Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT RTS REPORTED THE MAP WAS READING 129CMH2O WHILE ON PATIENT AND THAT VENT WOULD NOT SHUT OFF. RTS INDICATED THAT VENT PASSED PRE-USE CHECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19255587 ↗
• InjuryMay 1, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR KEEPS STOPPING. 3100 WAS ON A PATIENT WITH NO PATIENT HARM. INFORMED THAT THE 3100 WAS CONNECTED TO AN EXTERNAL BACK-UP POWER SOURCE AND FAILED. BIOMED CALLED THE MANUFACTURE AND WAS TOLD THAT EXTERNAL BACK-UP POWER SOURCE HAD FAILED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220406 ↗
• MalfunctionApr 29, 2024Failure to Recalibrate; Failure to Recalibrate

  IT WAS REPORTED TO VYAIRE THAT THE 3100A VENT¿S FREQUENCY PANEL METER ONLY REACHED 14.9. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202861 ↗
• MalfunctionApr 19, 2024Low Readings; Low Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THE 3100A WILL POWER ON, BUT WILL NOT START OSCILLATING, THE START/STOP SWITCH IS NOT FUNCTIONING. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143543 ↗
• MalfunctionApr 17, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT WILL NOT COMPLETELY POWER OFF BUT THE SCREENS WILL FREEZE AND THE DRIVER STOPS, AND THEN WILL START BACK UP AGAIN ON ITS OWN. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19124942 ↗
• InjuryApr 16, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THIS UNIT POWERED OFF WHILE ON A PATIENT. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19116101 ↗
• MalfunctionApr 16, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DRIVER INTERMITTENTLY WON'T START. BIOMED CONFIRMED THAT IT'S THE START/STOP BUTTON. THE BUTTON FEELS LIKE IT DOESN'T ENGAGE CORRECTLY LIKE THE OTHER BUTTONS. NEW DDI RESOLVED THE ISSUE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115310 ↗
• MalfunctionApr 15, 2024High Readings; High Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING A PRE-USE CHECK ON THE UNIT IT WAS NOTICED THAT WHEN THE STOPPER IS TAKEN OUT OF THE CIRCUIT, THE MAP WILL ONLY DROP TO 2.0CM. IT WILL NOT GO DOWN TO ZERO WITH ADJUSTING THE ZERO POT ON THE ALARM BOARD. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111815 ↗
• MalfunctionApr 15, 2024No Device Output; No Device Output

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS DE-PRESSURIZING WHILE ON PATIENT AND THEY COULD NOT GET IT TO RE-PRESSURIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105184 ↗
• InjuryApr 11, 2024No Pressure; No Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHILE ATTEMPTING TO ADJUST SETTING TO MAP OF 9CMH2O AND A DELTA P OF 24 ON THE 3100A THE VENT STOPS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19093857 ↗