HUDSON RCI IPN913861Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704660671), received between Jan 27, 2021 and Apr 29, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE RTS NOTICED A PUDDLE OF WATER UNDERNEATH THE NEPTUNE HEATER. THE WHITE PART IN THE CENTER OF THE CIRCLE IS THE WATER WICKING PAPER. ADDITIONALLY, NOTE THE BURN MARKS ON THE COLUMN FROM WATER LEAKAGE OUT OF THE HOLE AND DOWN ON TO THE FLOOR". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748113 ↗
• MalfunctionApr 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE RTS NOTICED A PUDDLE OF WATER UNDERNEATH THE NEPTUNE HEATER. THE WHITE PART IN THE CENTER OF THE CIRCLE IS THE WATER WICKING PAPER. ADDITIONALLY, NOTE THE BURN MARKS ON THE COLUMN FROM WATER LEAKAGE OUT OF THE HOLE AND DOWN ON TO THE FLOOR". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11748024 ↗
• InjuryApr 28, 2021Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED "ON MARCH 39TH, A 2 WEEK OLD ON VENTILATOR, IN PRVC SETTING, WAS NOT GETTING VOLUME DUE TO COLUMN. THE VENT WAS READING DELIVERED VOLUMES, BUT DUE TO THE COLUMN, THE PATIENT LUNGS WERE NOT. THE PATIENT HEART RATE INCREASED AND BECAME TACHYPNEIC IN NOTICEABLE WORK OF BREATHING. THE PATIENT RECEIVED AN EMERGENCY BRONCHOSCOPY, FLUID BOLUS AND ALMOST ARRESTED. WHEN THE THERAPIST NOTICED THEY WERE USING A SMART COLUMN. WHEN THE COLUMN WAS CHANGED, THEY WERE ABLE TO VENTILATE THE INFANT TO A STABLE CONDITION. NO DEATH OCCURRED. PATIENT CONDITION TODAY IS STABLE". IT WAS REPORTED THAT DEVICE WAS REPLACED.

  Patient problems: Ventilator Dependent

  MAUDE report 11740120 ↗
• MalfunctionJan 27, 2021False Alarm; False Alarm

  IT WAS REPORTED THE "RESPIRATORY THERAPIST NOTICED THAT THE NEPTUNE HEATER'S CAUTIONARY AND LOW WATER NOTIFICATIONS WERE ALARMING. THE WATER CUBE WAS REPLACED AND THE HEATER STILL ALARMED. THE RT THEN REPLACED THE CONCHA COLUMN AND THE ALARMS STOPPED". NO PATIENT INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236071 ↗