Vital Signs™ 8004463Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752190962), received between Dec 5, 2023 and Dec 5, 2023 — classified as 1 malfunction.

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

• MalfunctionDec 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8004463 EXHAUST LINE WITH COLDER WAS LEAKING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271100 ↗