HUDSON RCI IPN049742Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 14026704625366), received between Apr 19, 2021 and May 5, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.

• InjuryMay 5, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  MAUDE REPORT: IT WAS REPORTED "SILICONE O2 TUBING NOTED TO HAVE HARDENED AND WAS SWITCHED OUT FOR NEW TUBING. WOUND RN'S ASSESSED PATIENT AND IDENTIFIED: LEFT EAR - TOP OF EAR, STATE III, PREVIOUS PRESSURE INJURY; BOTTOM/MIDDLE, NEW PRESSURE INJURY DUE TO O2 TUBING, STAGE II - OFFLOAD AND APPLY SOOTHE AND COOL". PATIENT CONDITION UNKNOWN AT TIME OF REPORT.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11776823 ↗
• MalfunctionApr 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "PATIENT WAS ON CANNULA 1820 FOR 2-3 WEEKS, MAYBE LONGER. SKIN BREAKDOWN OCCURRED." UNKNOWN WHAT TYPE OF SKIN BREAKDOWN OCCURRED AT TIME OF REPORT. NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE."

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 11685754 ↗