PC 55-01-0017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00026072025260), received between Aug 26, 2025 and Mar 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 reports).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 26, 2026Gas/Air Leak

  WHEN CHANGING THE CO2 ABSORBENT, IT BECOMES DIFFICULT TO SEAL. RESULTS IN A CIRCUIT LEAK. VERY DANGEROUS TO PATIENT. FLOW SENSORS O2 RINGS FELL OUT OF MACHINE ALONG WITH THE ABSORBENT CONTAINERS, CAUSING CRNA TO MANUALLY VENTILATE THE PATIENT UNTIL THE ANES. TECH WAS ABLE TO PUT PART BACK IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24707078 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  AS HAS BEEN REPORTED BEFORE, THE ANESTHESIA MACHINE HAD A MAJOR LEAK HALFWAY THROUGH A CARDIAC CASE. THIS IS DUE TO THE CO2 ABSORBERS NOT BEING COMPATIBLE WITH THE ANESTHESIA MACHINES THAT DIVISIONAL SUPPLY CHAIN HAD DECIDED TO CHANGE WITHOUT CONSULTATION OF THE ANESTHESIA DEPARTMENT. IN THIS EVENT THE ANESTHESIA GAS FLOWS HAD TO BE ADJUSTED SIGNIFICANTLY UNTIL THE PATIENT WAS ABLE TO BE ON CARDIOPULMONARY BYPASS SO THE MACHINE COULD BE CHANGED OUT SINCE THE LEAK COULD NOT BE CHECKED AND THE MACHINE COULD NOT BE TROUBLESHOOTED WHILE A PATIENT WAS ACTIVELY CONNECTED TO THE MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900484 ↗