HUDSON RCI IPN046956Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704343970), received between Feb 23, 2021 and Mar 31, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjuryMar 31, 2021Material Separation; Material Separation

  IT WAS REPORTED "TUBING SEPARATED FROM WHITE CONNECTOR AT NASAL PRONGS, WHILE PATIENT WAS WEARING". IT WAS REPORTED PATIENT DESATURATED TO THE LOW 80S. IT WAS REPORTED THE DEFECTIVE CANNULA WAS REPLACED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Low Oxygen Saturation

  MAUDE report 11599630 ↗
• MalfunctionMar 10, 2021Material Separation; Material Separation

  IT WAS REPORTED "RT MANAGER STATES THERE WAS A PROBLEM AT THE CONNECTION TO THE CIRCUIT END REPORTED BY A TRAVELER THERAPIST. THE CONNECTION, PER THE THERAPIST, DISCONNECTED. THE ITEM WAS DISCARDED AND CHANGED. NO PATIENT INJURY". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11452967 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THE "COMFORT FLO PLUS IS BREAKING ON THE PATIENT AT THE NARES AND CORRUGATE TUBING". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364727 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THE "COMFORT FLO PLUS IS BREAKING ON THE PATIENT AT THE NARES AND CORRUGATE TUBING". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364720 ↗
• MalfunctionFeb 23, 2021Break; Break

  IT WAS REPORTED THE "COMFORT FLO PLUS IS BREAKING ON THE PATIENT AT THE NARES AND CORRUGATE TUBING". NO PATIENT HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364713 ↗