3100A HFOV 771465Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 50190752155464), received between Feb 13, 2023 and Feb 13, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Disconnection” (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 16, 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.

• InjuryFeb 13, 2023Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 771465 - CKT W/SHRT HTD WIRE 380-88 &400 BX4 WAS BECOMING DISCONNECTED WHILE ON THE PATIENT. THEY USED TAPE TO SECURE THE CIRCUIT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364719 ↗

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)