3100B HFOV 770155-RFBRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846446003468), received between Oct 27, 2020 and Jul 21, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE RESPIRATORY THERAPIST HAD TO MAX OUT THE POWER TO 10 ON THE 3100B VENTILATOR TO GET AN AMPLITUDE IN THE 50S. THE HZ WAS 5.5 AND IT (INSPIRATORY TIME) IS 50%. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077626 ↗
• MalfunctionMar 25, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED MEAN AIRWAY PRESSURE IS INACCURATE ON THE 3110 B VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911847 ↗
• MalfunctionOct 27, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR WILL NOT PRESSURIZE. 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 10743861 ↗