3100B HFOV 11744-850KRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50190752155150), received between Oct 28, 2021 and Oct 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE HFOV 3100B VENTILATOR TUBING EXPERIENCED VENTILATOR SHOWING "OSCILLATOR STOPPED" ALARM. FOUND DAMAGED PATIENT BREATHING CIRCUIT'S DIAPHRAGM AFTER USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. AS AN INTERVENTION, REPLACED PATIENT BREATHING SET AND RESUME THE VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715940 ↗

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)