HUDSON RCI IPN040620Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04026704581290), received between Jan 26, 2021 and Oct 28, 2021 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE USER FOUND IT DIFFICULT TO CONNECT THE ADAPTOR TO THE FLOWMETER AS THE CONNECTING PART WAS SO UNSTABLE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12712389 ↗
• MalfunctionAug 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE CONNECTION PART BETWEEN THE NUT ADAPTOR AND THE FLOWMETER WAS SO UNSTABLE THAT THE ADAPTOR GOT DETACHED DURING USE. THEREFORE, IT WAS REPLACED WITH A NEW UNIT". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12355437 ↗
• MalfunctionJul 14, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT "THE USER FOUND THE OXYGEN DID NOT SEEM TO FLOW DURING USE AS HE/SHE SAW THE BALL OF A FLOATING TYPE FLOWMETER DID NOT FLOAT. THEREFORE, HE/SHE REPLACED THE NEBULIZER ADAPTOR WITH ANOTHER ONE, THEN THE OXYGEN FLOWED WITHOUT PROBLEM". NO PATIENT INJURY OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12169586 ↗
• MalfunctionJun 3, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE USER FOUND THE CONNECTION PART BETWEEN THE NUT ADAPTOR AND THE FLOWMETER WAS UNSTABLE DURING USE. ALSO, THE FLOW RATE SEEMED TO BE DECREASING. THEREFORE, IT WAS REPLACED WITH A NEW UNIT". NO PATIENT HARM OR CONSEQUENCE REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934784 ↗
• MalfunctionMay 6, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "WHEN THE USER CONNECTED THE NUT ADAPTOR TO THE FLOWMETER BEFORE USE ON A PATIENT, THE CONNECTING PART WAS UNSTABLE. ALSO, IT SEEMED THAT WATER LEAKED FROM THE COLLAR OF THE ADAPTOR. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11783239 ↗
• MalfunctionApr 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE USER FOUND THE CONNECTION PART BETWEEN THE NUT ADAPTOR AND THE FLOWMETER WAS UNSTABLE BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11710945 ↗
• MalfunctionApr 5, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE USER FELT DIFFICULTY TO CONNECT THE NUT ADAPTOR TO THE FLOWMETER BEFORE USE ON A PATIENT. AFTER CONNECTING, THE CONNECTION PART BETWEEN THE ADAPTOR AND THE FLOWMETER WAS UNSTABLE. THEREFORE, THE ADAPTOR WAS REPLACED WITH A NEW UNIT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11613138 ↗
• MalfunctionMar 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED "THE USER FOUND THE CONNECTION PART BETWEEN THE NUT ADAPTOR AND THE FLOWMETER WAS UNSTABLE BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528187 ↗
• MalfunctionMar 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED "THE CONNECTING PART OF THE ADAPTOR TO THE FLOWMETER WAS UNSTABLE AND THE ADAPTOR GOT DETACHED DURING USE. THE ADAPTOR WAS REPLACED WITH A NEW UNIT, BUT THE SAME ISSUE OCCURRED. THE THIRD UNIT WAS CONNECTED PROPERLY". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11528137 ↗
• MalfunctionMar 19, 2021Connection Problem; Connection Problem

  IT WAS REPORTED "THE CONNECTING PART OF THE ADAPTOR TO THE FLOWMETER WAS UNSTABLE AND THE ADAPTOR GOT DETACHED DURING USE. THE ADAPTOR WAS REPLACED WITH A NEW UNIT, BUT THE SAME ISSUE OCCURRED. THE THIRD UNIT WAS CONNECTED PROPERLY". NO PATIENT HARM OR INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11527979 ↗
• MalfunctionFeb 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT "THE USER FELT THE CONNECTION PART BETWEEN THE ADAPTOR AND THE FLOWMETER WAS UNSTABLER THAN USUAL DURING USE. THEREFORE, THE ADAPTOR WAS REPLACED WITH A NEW UNIT". NO HARM TO THE PATIENT OCCURRED". THE CONDITION OF THE PATIENT WAS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11362478 ↗
• MalfunctionJan 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "WATER WAS FOUND LEAKING FROM THE COLLAR OF THE ADAPTOR WHILE IN USE ON A PATIENT. THEREFORE, THE ADAPTOR WAS REPLACED WITH A NEW UNIT". NO PATIENT INJURY REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11231206 ↗