Vital Signs™ A5U580A4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752120792), received between Feb 11, 2021 and Sep 17, 2021 — classified as 2 malfunctions.

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

• MalfunctionSep 17, 2021Disconnection; Disconnection

  THE CUSTOMER REPORTED A LOOSE CONNECTION BETWEEN THE ELBOW AND THE HMU FILTER RESULTED TO A DETACHMENT OF THE GSE FROM EDITH 1000 HME AND EDITH 1000 HME FROM THE PATIENT WYE ON THE SUTTER HEALTH FORMULARY A5U580A4 VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT, LOT 0004188508. MOST TIMES THE OPERATING TIME IS INCREASED DUE TO THE CIRCUIT FALLING APART. AND FOR THIS REPORTED INCIDENT, THE ISSUE CAUSED A DISRUPTIONS AND ROOM GAS CONTAMINATION DURING SURGERY. THE ISSUE OCCURRED DURING PATIENT-USE AND AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12490642 ↗
• MalfunctionFeb 11, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT ARE BEING BUILT WITH A DIFFERENT HME (HEAT AND MOISTURE EXCHANGER) SIZE. THE HME LOCATED BETWEEN THE ELBOW AND WYE OF THE AFFECTED CIRCUITS ARE VISIBLY MUCH SMALLER THAN THEY SHOULD BE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11317999 ↗