Vital Signs™ A4U12214Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752119871), received between Jul 12, 2022 and Aug 24, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionAug 24, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ADULT MASK IN A4U12214 - ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG DOES NOT PROVIDE AN APPROPRIATE SEAL AROUND THE PATIENT'S AIRWAY DESPITE SEVERAL ATTEMPTS TO RE INFLATE. THERE WAS PATIENT INVOLVEMENT. 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 15286996 ↗
• MalfunctionJul 12, 2022Defective Component; Defective Component

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MASK FOR VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT DOES NOT PROVIDE AN APPROPRIATE SEAL AROUND THE PATIENT'S AIRWAY AND THIS POSSESSES A GREAT RISK TO PATIENT CARE AND OUTCOMES. THERE WAS PATIENT INVOLVEMENT BUT NO KNOWN CONSEQUENCE OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988154 ↗