Ventlab AF5040MBPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889483161074), received between Jul 25, 2025 and Jul 17, 2026 — classified as 3 malfunctions.

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

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.

• MalfunctionJul 17, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25855314 ↗
• MalfunctionNov 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WERE DIFFICULTIES CONNECTING THE RESUSCITATION MASK TO THE BAG BECAUSE THE INCLUDED MASK WAS NOT SUFFICIENTLY INFLATED WHEN REMOVED FROM THE PACKAGING. INFLATION WITH A SYRINGE WAS REQUIRED. THERE WERE NO DELAYS IN THERAPY, HARM, OR INJURY REPORTED AS A RESULT OF THIS ISSUE. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00100 FOR THE SECOND REPORT.

  Patient problems: Insufficient Information

  MAUDE report 23622243 ↗
• MalfunctionJul 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE RESUSCITATION BAG BROKE APART AS THEY WERE PLACING IT ON THE PATIENT, WHO WAS CODING; ANOTHER BAG WAS USED AS THIS ONE WAS UNABLE TO PROVIDE POSITIVE PRESSURE. THERE WAS A SLIGHT DELAY IN RESUSCITATION; HOWEVER, THE STAFF WAS ABLE TO GIVE THE PATIENT O2 BY HOLDING THE BAG TOGETHER, UNTIL ANOTHER BAG WAS PROCURED. THERE WAS NO REPORTED INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22615581 ↗