Ventlab AF1140MBRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483071809), received between Jun 21, 2023 and Jun 21, 2023 — classified as 1 malfunction.

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

• MalfunctionJun 21, 2023Deflation Problem; Deflation Problem

  MASKS ARE DEFLATED AND WILL NOT PROPERLY SEAL ON PATIENTS FACE. CUSTOMER STATED THE FOLLOWING: THIS ISSUE IS PLACING OUR PATIENTS AT GREAT RISK IN THE EVENT A CODE BLUE IS CALLED, THE MASK WILL NOT PROPERLY SEAL ON THE PATIENTS FACE.

  Patient problems: Hypoxia

  MAUDE report 17175394 ↗