3100A/B 22151-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846446005776), received between Mar 23, 2020 and Apr 8, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P890057); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR SHUT DOWN WHILE ON A PATIENT AND WAS MOVED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ON THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9935926 ↗
• MalfunctionMar 23, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THEIR 3100A VENTILATOR CENTERING POT IS NOT VERY STABLE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 9869279 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P890057. One submission often covers many models, so check the product and lot details in each record.

• Z-0488-2024 · Oct 27, 2023 · Completed
  vyaire Flexible Patient Circuit, 3100A, REF 29028-003, intended to be used with the 3100A High Frequency Oscillatory Ventilator (HFOV)