Vital Signs™ AFRXXXXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752122574), received between Feb 4, 2022 and Jan 18, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• MalfunctionJan 18, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AFRXXXXX - ANES CIRCUIT, ADULT, 60 IN LIMBO CO2 PORT CAP IS LOOSE AND FAILED LEAK TEST DURING PATIENT USE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16191947 ↗
• MalfunctionFeb 4, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CONNECTION BETWEEN AFRXXXXX LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT AND RESPIRATOR WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT, AS THE ISSUE WAS DETECTED PRIOR TO THE LEAK TEST. HOWEVER, THIS ISSUE HAS A HIGH RISK OF MEDICAL ACCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13454706 ↗