Vital Signs™ AFNXXXXXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752122239), received between Nov 9, 2020 and Jun 6, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2023Leak/Splash; Infusion or Flow Problem; Leak/Splash; Infusion or Flow Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING SURGERY, THE ANES CIRCUIT, ADULT, 72 IN LIMBO LEAKS AIR AND WAS UNABLE TO VENTILATE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073447 ↗
• InjuryNov 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING SURGERY THE AFNXXXXX ANES CIRCUIT, ADULT, 72 IN LIMBO HAD A LEAK FROM THE TUBE. THE CUSTOMER CONFIRMED THAT THE TUBE WAS CHANGED IMMEDIATELY AND THAT THE REPORTED EVENT DID NOT HARM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15886758 ↗
• MalfunctionMay 11, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DURING THE 8-HOUR OPERATION, THE LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT EXPERIENCE A LEAK TEST ERROR AND NO L-SHAPED CONNECTOR. THERE WAS NO IMPACT ON PATIENTS AND MEDICAL PRACTICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807663 ↗
• InjuryNov 9, 2020Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT EXPERIENCED DISCONNECTION WITH THE AIR FILTER AND CIRCUIT AFTER ANESTHESIA WITH THE PATIENT. LATER, THE PATIENT BECAME PEA AND TOOK LIFE-SAVING MEASURES, AND NOTICED THAT THE AIR FILTER AND CIRCUIT HAD BEEN DISCONNECTED AGAIN AFTER THE HEARTBEAT RESUMED. AS AN INTERVENTION, WHEN THE PATIENT HAD PEA (PULSELESS ELECTRICAL ACTIVITY; IT MEANS A CARDIOPULMONARY ARREST), A RESUSCITATION WAS ATTEMPTED. AND THEN, THE CARDIOPULMONARY OF THE PATIENT HAS REGAINED. THE HOSPITAL INDICATED THAT THE PATIENT MAY HAVE BECOME APNEA DUE TO THE DISCONNECTION BETWEEN THE CIRCUITS.

  Patient problems: Apnea

  MAUDE report 10813944 ↗