HUDSON RCI IPN913994Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 14026704657169), received between Jul 23, 2021 and Nov 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2021No Flow; No Flow

  IT WAS REPORTED THAT: "THE PATIENT'S HUSBAND NOTICED THAT THE FLOW RATE BALL OF CONCENTRATOR 02 WAS < 4L / MIN. HE ALSO OBSERVED HE COULD NOT INCREASE THE FLOW. HE REMOVED THE HUMIDIFIER; THE CONSEQUENCE WAS THAT THE CONCENTRATOR HAD A PROPERLY WORKING FLOW. HE REMOVED THE MICRO- DIFFUSER AND THE FLOW WAS ALSO NORMAL. WE OBSERVED THAT THE DIFFUSER IS "HARD" (LIMESTONE ) WHEREAS THE WATER USED BY THE PATIENT IS LOW IN LIMESTONE. THE DIFFUSER WAS ONLY USED FOR 15 DAYS. THE DIFFUSER JAR WAS CLEAN". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800469 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT: "THE INCIDENT INVOLVED A (B)(6) MALE PATIENT. RECEIVING 2 LITER PER MINUTE. 7 HOURS DURING DAY TIME, 8 HOURS DURING THE NIGHT TIME. THE PLASTIC ROD INSIDE THE DEVICE DETACHED FROM THE COVER. THEN IT WAS LOOSE INSIDE THE RESERVOIR. THE OXYGEN WAS NO LONGER PASSING THROUGH". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647086 ↗
• MalfunctionJul 23, 2021No Flow; No Flow

  IT WAS REPORTED THAT: "AFTER A WEEK OF USE, THE O2 FLOW IS NO LONGER DELIVERED. IT MAKES NOISE. BY REMOVING THE WHITE FILTER, THE FLOW RETURNS TO NORMAL". NO PATIENT INJURY OR HARM REPORTED. PATIENT CONDITION UNKNOWN AT TIME OF REPORT. REQUEST FOR ADDITIONAL INFORMATION HAS BEEN UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12220890 ↗