HUDSON RCI IPN044418Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04026704348176), received between May 16, 2022 and Sep 4, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  IT WAS REPORTED THAT"(B)(6) 2024, BEFORE THE NURSE PREPARED TO REPLACE THE PATIENT'S ARTIFICIAL NOSE, SHE FOUND WATER DROPLETS INSIDE THE UNOPENED PACKAGE. THIS WAS DISCARDED IMMEDIATELY AND REPLACED WITH A NEW INTACT PRODUCT TO COMPLETE THE PROCEDURE WITHOUT ADVERSE EFFECT TO THE PATIENT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134230 ↗
• MalfunctionNov 9, 2022Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT "WE ARE USING THESE TRACH-VENT SINCE JULY 2022. WE ARE FACING DIFFICULTY CONNECTING TO THE TRACHEOSTOMY TUBES. ARTIFICIAL NOSES DO NOT CONNECT TO IT (THE ORIFICE IS TOO SMALL)." FURTHER INFORMATION STATES, "THERE WAS NO CONSEQUENCE FOR THE PATIENT, NO DESATURATION. THE DOCTOR DID A DIY SYSTEM TO MAKE SURE THE TRACH-VENT WAS CONNECTING TO THE TUBE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15764230 ↗
• MalfunctionOct 28, 2022Compatibility Problem; Compatibility Problem

  THE REPORT STATES THAT THE "INCIDENT OCCURRED IN THE RESUSCITATION ROOM ON (B)(6) 2022. THE CONNECTION OF THE TRACK-VENT ON THE CANNULA IS DIFFICULT, THE GAUGES DO NOT MATCH. THIS MAKES THE PROCEDURE PAINFUL FOR THE PATIENT. [THE CLINICIANS] OBSERVED DURING COUGHING EFFORTS THAT THE TRACK-VENT DISCONNECTED FROM THE CANNULA WHICH LED TO EPISODES OF DESATURATION IN THE PATIENT." FURTHER INFORMATION STATES THAT "THE MEDICAL INTERVENTION WAS TO GIVE [OXYGEN] BACK TO THE PATIENT AND MONITOR." THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: Low Oxygen Saturation; Pain

  MAUDE report 15691344 ↗
• MalfunctionJun 6, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT: "THE FILTER WAS CONNECTED TO A TRACHEOTOMY TUBE. THE FILTER DID NOT FIT INTO THE CANNULA. THE ATTACHMENT WAS LOOSE, THE FILTER WAS HANGING DOWN AND THUS OXYGENATION WAS IMPOSSIBLE. IT WAS THEN NECESSARY TO CHANGE THE CANNULA TO CONNECT THE FILTER". ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT DID NOT EXPERIENCE ANY DESATURATION. THE DEVICE WAS CHANGED AND THERE WAS NO CONSEQUENCE FOR THE PATIENT. NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Discomfort

  MAUDE report 14605523 ↗
• InjuryMay 16, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "THERE WAS AN EXTRA VALVE INCLUDED IN THE HUMIDIFIER RENDERING THE PRODUCT USELESS AND OBSTRUCTING OUR PATIENTS AIRWAY". DEVICE WAS USED IN THE HOME ENVIRONMENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAS AN EXISTING TRACHY AND THE ISSUE WAS CORRECTED BY REMOVING THE DEFECTIVE DEVICE AND REPLACING IT. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407114 ↗