Vital Signs™ A4UX2044Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752120006), received between Nov 8, 2021 and Nov 8, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER FILE THE REGULATORY REPORT UNDER UF REPORT# (B)(4). REPORTING AN ISSUE ON A4UX2044 VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT WITH A SMALL HOLE IN THE SEAM AT THE END OF THE BAG. THERE IS NO INFORMATION ON PATIENT INVOLVEMENT, HOWEVER, THE ISSUE OCCURRED IN THE OPERATING ROOM.

  Patient problems: Insufficient Information

  MAUDE report 12776024 ↗