imtmedical pte 301.328.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640149381344), received between Jun 28, 2021 and Sep 14, 2022 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K183364); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA-IFLOW SENSOR TUBING FELL ON THE FLOOR WITH PIECE ATTACHED AND IT BROKE INTO TWO SEPARATE PIECES CLEANLY.THE ISSUE OCCURRED DURING PATIENT-USE AND AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419697 ↗
• InjuryNov 18, 2021Defective Component; Defective Component

  THE CUSTOMER REPORTED BELLAVISTA - IFLOW 200S SENSOR CAME APART WHILE ON A PATIENT. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE PATIENT WAS REMOVED FROM THE VENTILATOR DUE TO PROBLEM BUT NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836993 ↗
• InjurySep 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT WHILE ON A PATIENT, THE FLOW 200 S PROXIMA FLOW SENSOR OF BELLAVISTA SPLITTING AT THE SEAM. FURTHERMORE, PATIENT WAS BAGGED WITH AMBU BAG AND FLOW SENSOR WAS CHANGED TO ANOTHER ONE BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514498 ↗
• MalfunctionJul 20, 2021Disconnection; Disconnection

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE GREEN COMPONENT OF THE IFLOW 200 S WAS DISCONNECTED FROM MAIN PART OF THE FLOW SENSOR HAPPENED PRIOR CONNECTING THE PATIENT TO VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS A DELAY IN CONNECTING WHILE WAITING FOR ANOTHER FLOW SENSOR YET NO PATIENT HARM WAS REPORTED. THREE (3) OUT OF 10 SENSORS WERE DEFECTIVE WHICH CONFIRMED HAPPENED INTO THREE(3) SEPARATE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200014 ↗
• MalfunctionJul 20, 2021Disconnection; Disconnection

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE GREEN COMPONENT OF THE IFLOW 200 S WAS DISCONNECTED FROM MAIN PART OF THE FLOW SENSOR HAPPENED PRIOR CONNECTING THE PATIENT TO VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS A DELAY IN CONNECTING WHILE WAITING FOR ANOTHER FLOW SENSOR YET NO PATIENT HARM WAS REPORTED. THREE (3) OUT OF 10 SENSORS WERE DEFECTIVE WHICH CONFIRMED HAPPENED INTO THREE(3) SEPARATE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199969 ↗
• MalfunctionJun 28, 2021Disconnection; Disconnection

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE GREEN COMPONENT OF THE IFLOW 200 S WAS DISCONNECTED FROM MAIN PART OF THE FLOW SENSOR HAPPENED PRIOR CONNECTING THE PATIENT TO VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS A DELAY IN CONNECTING WHILE WAITING FOR ANOTHER FLOW SENSOR YET NO PATIENT HARM WAS REPORTED. THREE (3) OUT OF 10 SENSORS WERE DEFECTIVE WHICH CONFIRMED HAPPENED INTO THREE(3) SEPARATE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076231 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K183364. One submission often covers many models, so check the product and lot details in each record.

• Z-1967-2023 · May 5, 2023 · Completed
  bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
• Z-1966-2023 · May 5, 2023 · Completed
  bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
• Z-0622-2022 · Dec 20, 2021 · Terminated
  bellavista 1000 ventilator, Catalog #301.100.030 and bellavista 1000e ventilator, 301.100.130. The bellavista 1000/1000e ventilator is intended to provide positive pressure ventil