Vital Signs™ AFN52004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752121775), received between Mar 27, 2022 and Dec 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED TO VYAIRE MEDICAL DURING SCHEDULED PM (PREVENTIVE MAINTENANCE), BLUE PLASTIC FLECKS IN ANESTHESIA MACHINE. THE AFN52004 - ANES CIRCUIT, ADULT, 72 IN LIMBO, 3L BAG SHEDDING BLUE PLASTIC FLECKS INTO THE MACHINE AND POSSIBLY INTO THE PATIENT. THE CUSTOMER NOTED THAT THERE WERE QUESTIONS AS TO WHETHER THE BLUE FLECKS WERE FROM VYAIRE¿S AFN52004 ANESTHESIA CIRCUITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990759 ↗
• InjuryMar 27, 2022Failure to Disconnect; Failure to Disconnect

  THE CUSTOMER REPORTED AN INCIDENT WITH AFN52004 LIMB-O¿ SINGLE LIMB ANESTHESIA BREATHING CIRCUIT. THE ANESTHETIST RUNNING FLOWS AT 10 LITERS INITIALLY WITH ADJUSTMENTS AS HIGH AS 16 LITERS. RUNNING 2.3 SEVOFLURANE DURING WHOLE CASE. ANESTHETIST TURNED GAS OFF EARLY TO FINISH CASE. DURATION OF SEVOFLURANE GAS OFF FROM 535 TO 550 BEFORE BEING ABLE TO EXTUBATE AT 553. EXP SEVOFLURANE GAS READ AT 0.2 AND UNABLE TO REDUCE IN TIMELY FASHION. CORRECTIVE MEASURES TAKEN INCLUDED FLUSHING CIRCUIT WITH FRESH GAS, STILL WITHOUT TIMELY REDUCTION IN EXP SEVOFLURANE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925185 ↗