iFlow 301.328.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07640149388985), received between Sep 24, 2022 and Jan 25, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (2 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. How this data works · Data updated Oct 13, 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.

• InjuryJan 25, 2023Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH IFLOW 200S PLUS FLOW SENSOR WHERE PATIENT WAS BEING TURNED IN THE PROCESS OF PERSONAL CARE, THE DEVICE SNAPPED AND CAUSED THE PATIENT'S ET (ENDOTRACHEAL) TUBE TO BECOME DISCONNECTED FROM THE VENTILATOR. FURTHERMORE, THERE WAS NO HARM DUE TO THE SWIFT REACTION OF STAFF TO BAG THE PATIENT UNTIL DEVICE COULD BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16244972 ↗
• InjuryJan 18, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 HAD A CRACKED FLOW SENSOR DURING PATIENT USE. FURTHERMORE, THE PATIENT WAS INTUBATED AND SEDATED ON AN ACVC VENTILATOR. THE IFLOW 200S ADULT PROXIMAL FLOW SENSOR SNAPPED WHILE THE PATIENT WAS BEING TURNED FOR CLEANING BY NURSING STAFF, RESULTING IN A DISCONNECT BETWEEN THE PATIENT'S ET TUBE AND THE VENTILATOR. THE PATIENT'S SPO2 BEGAN TO FALL, AND WAS NOT TAKING SPONTANEOUS BREATHS DUE TO SEDATION; THE PATIENT NEEDED TO BE BAG-MASK-VENTILATED FOR 3-4 MINUTES BEFORE THE TUBING WAS REPLACED BY RT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191539 ↗
• InjurySep 24, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA VENTILATOR TUBE GOT DISCONNECTED FROM ETT (ENDOTRACHEAL TUBE) AND FELL ON FLOOR. THE ADAPTER SECTION IN VENT CIRCUIT WAS COMPLETELY SPLIT. THE PATIENT WAS MANUALLY VENTILATE WITH BAG VALVE MASK. PATIENT WAS DESATURATED TO 64% AND QUICKLY RECOVERED AFTER BAG VALVE MASK VENTILATON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15481133 ↗