DAR 351/5856Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884522033128), received between May 20, 2025 and Sep 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Use of Device 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE LEAK TEST WAS NOT POSSIBLE DURING THE PRE-USE CHECK OF THE ANESTHESIA MACHINE IN THE OPERATING ROOM. EVEN AFTER REPLACING THE CIRCUIT, IT WAS NOT RESOLVED. BUT WHEN THE FILTER WAS REPLACED, THE TESTING WAS ABLE TO PERFORM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23045635 ↗
• MalfunctionMay 20, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE TEST ON THE RESPIRATORY SIDE OR LEAK TEST DID NOT PASS BEFORE THE PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055310 ↗