Vital Signs™ AFN580ACRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752121867), received between May 12, 2021 and May 12, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2021Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT THE (S)SUB MASK/SIZE 5/ADULT EXPERIENCED VERY DEFLATED WHICH MAKES IT DIFFICULT TO GET A QUALITY SEAL TO MASK VENTILATE PATIENTS. AS AN INTERVENTION, ANESTHESIA TECHNICIANS MANUALLY INFLATE THE MASK VIA THE TAIL VALVE USING A SYRINGE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815474 ↗