HUDSON RCI IPN913836Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 14026704660398), received between Apr 16, 2021 and Jun 30, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Melted” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2021Melted; Melted

  IT WAS REPORTED "THE CIRCUIT MELTED, CLOSE TO THE PATIENT END. THE PATIENT WAS ON HFNC DURING THE DAY. THE RN TOUCHED THE CIRCUIT AND REALIZED IT WAS REALLY HOT. AT THIS TIME THE PATIENT WAS ON BIPAP FOR THE EVENING AND NOT ON THE HFNC. THEY DISCOVERED THAT THEY HAD TURNED THE FLOW OFF ON THE HFNC BUT HAD NOT TURNED THE HEATER OFF. THE PATIENT WAS NOT WEARING THE SET UP, SO IT WAS NOT "DURING USE ON PATIENT"". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091727 ↗
• MalfunctionJun 9, 2021Melted; Melted

  COMPLAINT FROM MAUDE DATABASE: HEATED HIGH FLOW CANNULA SYSTEM (TELEFLEX NEPTUNE HEATER AN CONCHASMART BREATHING SYSTEM WITH SINGLE LIMB) WAS FOUND OFF THE PATIENT LAYING ON THE PATIENT'S BED. THE HEATER WAS ON AND THE FLOWMETER WAS ON. AN AREA OF THE CORRUGATED TUBING WAS OBSERVED TO BE MELTED WITH AN OPEN HOLE. THE PATIENT WAS ON BIPAP. NO INJURY TO THE PATIENT. TREATMENT START ON (B)(6) 2021. DIAGNOSIS FOR COVID-19, SEVERE ARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968654 ↗
• MalfunctionJun 7, 2021Melted; Melted

  IT WAS REPORTED "THE CIRCUIT MELTED". UNKNOWN AT TIME OF REPORT WHERE ISSUE WAS OBSERVED. UNKNOWN PATIENT CONDITION AT TIME OF REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11952413 ↗
• MalfunctionApr 20, 2021Melted; Melted

  IT WAS REPORTED "THE CIRCUIT MELTED WHILE ON THE PATIENT. THE PATIENT WAS ON A TRACH COLLAR AND OUR HEATER. THE PATIENT'S CIRCUIT MELTED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11697293 ↗
• MalfunctionApr 20, 2021Melted; Melted

  IT WAS REPORTED "CIRCUIT MELTED". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11696897 ↗
• InjuryApr 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "THE CONNECTION AT THE CLEAR CONNECTOR THAT GOES ON THE COLUMN BECOMES DISCONNECTED VERY EASILY, EITHER BY HAND OR ON THE COLUMN. THIS INCIDENT HAPPENED ONE TIME. THIS INCIDENT FOR THIS COMPLAINT WAS A DETACHMENT AND IT EFFECTED THE PATIENT, CAUSING THEM TO CODE, BUT IT TURNED OUT THAT THEY INTUBATED THE PATIENT AND THE PATIENT IS NOW FINE AND HAS COME OFF THE VENTILATOR". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 11679712 ↗