Vital Signs™ AFNX1900Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752121973), received between Oct 14, 2022 and Nov 1, 2022 — classified as 2 injuries.

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

• InjuryNov 1, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER PLACING THE LARYNGEAL MASK ON THE PATIENT, A LEAK WAS DETECTED IN THE SYSTEM. THEY SUSPECTED THAT THE MASK WAS CAUSING THE LEAK, THEY PROCEEDED TO CHANGE IT. AS THE LEAK PERSISTS, THE ENTIRE CIRCUIT WAS INSPECTED AGAIN, AND A CRACK WAS DETECTED ON AFNX1900 - ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG ON THE CORRUGATED CIRCUIT.THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710257 ↗
• InjuryOct 14, 2022Complete Blockage; Complete Blockage

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT WHILE THE PATIENT IS INTUBATED THE ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG HAD A PLASTIC BARRIER WHICH PREVENTED THE OXYGEN FROM ENTERING THE CORRUGATED TUBE. ALTERNATIVE VENTILATION WAS PROVIDED AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15609746 ↗