3100A HFOV 768901-RFB (UDI 10846446003024)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10846446003024), received between Mar 3, 2020 and Jul 19, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (15 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR WAS EXPERIENCING FREQUENCY ISSUES. THE UNIT IS SHUTTING DOWN WHEN TRYING TO RAISE THE FREQUENCY. THE ISSUE OCCURRED DURING PATIENT-USE. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058355 ↗
• MalfunctionApr 28, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENT IT (INSPIRATORY TIME) WAS ONLY READING 9%. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14247251 ↗
• MalfunctionApr 26, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAS ISSUE WITH FREQUENCY. UNIT IS SHUTTING DOWN WHEN TRYING TO RAISE THE FREQUENCY. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE EVENT HAPPENED DURING PATIENT USE AND THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14215296 ↗
• MalfunctionApr 25, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT 3100A VENT IS HAVING ISSUES WHEN ADJUSTING THE FREQUENCY TO 13 WHILE ON A PATIENT. THE CUSTOMER CONFIRMED THAT NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197900 ↗
• MalfunctionFeb 16, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE DEVICE WILL AUTOMATICALLY START OSCILLATING WHEN THE UNIT IS TURNED ON THE 3100 A DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544085 ↗
• MalfunctionFeb 10, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR IS NOT PRESSURIZING, AND THE CUSTOMER WANTED TO ORDER A 7-YEAR PM KIT. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510243 ↗
• MalfunctionFeb 4, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR IS NOT PRESSURIZING. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454537 ↗
• MalfunctionDec 3, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE 3100A VENTILATOR %IT (PERCENTAGE INTERVAL TIME) IS FLUCTUATING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925842 ↗
• MalfunctionOct 5, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAD A BURNING SMELL AND THEY COULD NOT GET IT TO START. THE ISSUE HAPPENED DURING PRE-USE CHECKS. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577292 ↗
• MalfunctionSep 6, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE AMPLITUDE IS UNSTABLE ON THE 3100 A VENTILATOR . THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12428685 ↗
• MalfunctionJul 27, 2021Mechanical Problem; Mechanical Problem

  FREQ POT ONLY GOES TO 14.9 . CALLED FOR P/N OF POT. HE WILL ORDER AND INSTALL HIMSELF TO COMPLETE REPAIR. MDM CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228156 ↗
• MalfunctionMar 31, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR WAS NOT SHOWING ANY NUMBERS OF INSPIRATORY TIME ON THE DISPLAY . AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599807 ↗
• MalfunctionMar 26, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE 3100A VENTILATOR STARTS THEN STOPPED AFTER A FEW MINUTES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576567 ↗
• MalfunctionMar 8, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED FLUCTUATING MEAN AIRWAY PRESSURE ON A PATIENT ON THE 3100 A VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436969 ↗
• MalfunctionDec 22, 2020Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR HAS A LEAK HEARD FROM THE REGULATORS IN THE PNEUMATICS. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060510 ↗
• MalfunctionAug 25, 2020Infusion or Flow Problem; Infusion or Flow Problem

  IT IS REPORTED TO VYAIRE MEDICAL THAT 3100A VENTILATOR EXPERIENCED A FLUCTUATING MAP BETWEEN 53-58 CM ON THE DISPLAY WHILE CHECKING THE ZERO/SPAN ON THIS UNIT. THE EXTERNAL METER IS READING STABLE AT 37 CM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10451808 ↗
• MalfunctionMar 18, 2020Gas Output Problem; Gas Output Problem

  THE CUSTOMER REPORTED THAT THE 3100A IS GIVING LOW SOURCE GAS LIGHT SIGNAL WHILE ON A PATIENT USE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9850480 ↗
• MalfunctionMar 3, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE 3100A MAP (MAIN AIRWAY PRESSURE) WAS FLUCTUATING AND THE AMP READING IS 2. THE DEVICE WAS RUNNING ON A PATIENT AND WAS TRANSFERRED TO ANOTHER VENTILATOR. CUSTOMER CONFIRMED NO PATIENT HARM IN THIS REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780500 ↗