HUDSON RCI IPN049908Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704641090), received between Mar 30, 2021 and Mar 30, 2021 — 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. 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.

• MalfunctionMar 30, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "BOTH THE UNITS GAVE AN ALARM OF A LEAK IN THE CIRCUIT WHEN THEY ATTACHED THEM TO THE SAME ANAESTHETIC MACHINE. ON THE THIRD UNIT THE ISSUE WAS RESOLVED. CLINICAL CONSEQUENCES: NONE - PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592321 ↗
• MalfunctionMar 30, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "BOTH THE UNITS GAVE AN ALARM OF A LEAK IN THE CIRCUIT WHEN THEY ATTACHED THEM TO THE SAME ANAESTHETIC MACHINE. ON THE THIRD UNIT THE ISSUE WAS RESOLVED. CLINICAL CONSEQUENCES: NONE - PRIOR TO USE ON A PATIENT DURING INSPECTION/FUNCTIONAL TESTING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592274 ↗