Ventlab AF1140MB-PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483098370), received between Feb 16, 2023 and Feb 16, 2023 — classified as 1 malfunction.

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

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 11, 2023Open, Classified

   A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

   Z-0361-2024 · Root cause: Device Design · Recall details · FDA record ↗

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.

• MalfunctionFeb 16, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING INTUBATION THE BAG BROKE APART. POSSIBLE DELAY IN INTUBATION BUT NO DETAILS GIVEN ON THE PATIENT AFFECT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 16386883 ↗