Vital Signs® M1152226Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752136908), received between Aug 20, 2022 and Oct 12, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY NOTICED MINOR LEAKED ON M1152226 - CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE INTRA-OPERATIVELY. INITIALLY, MACHINE TESTED PASSED WITHOUT LEAK. THEY CHANGED OUT THE CIRCUIT AT THE END OF CASE AND THEY ENCOUNTERED SLIGHT DELAY AS NEW CIRCUIT WAS NEEDED TO BE APPLIED. THE PATIENT WAS STABLE BEFORE AND AFTER THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15592208 ↗
• MalfunctionAug 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CIRCUIT COAX (A) 2.4M, B.EXT, 2L BAG GSE EXPERIENCED LEAKS GREATER THAN 750 MLS. THE INCIDENT OCCURRED DURING TESTING IN BETWEEN PATIENTS. THE OCCURRENCE CAUSED SIGNIFICANT DELAYS IN THE OPERATING LISTS. THERE WERE NO REPORTS OF INJURY/HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15263317 ↗