HUDSON RCI IPN913684Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704658890), received between Feb 2, 2021 and Jun 1, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (4 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.

• MalfunctionJun 1, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED "VENT CIRCUIT FAILED VENTILATOR PRE-TESTING BECAUSE OF "ILL FITTING" CONNECTIONS ON THE CIRCUIT". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11916047 ↗
• MalfunctionFeb 2, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED "THE ADAPTERS ON THE END THAT ATTACH TO THE INSPIRATORY AND EXPIRATORY SIDE ARE NOT TIGHT AND NOT PASSING PRE-USE CHECK". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268167 ↗
• MalfunctionFeb 2, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED "THE ADAPTERS ON THE END THAT ATTACH TO THE INSPIRATORY AND EXPIRATORY SIDE ARE NOT TIGHT AND NOT PASSING PRE-USE CHECK". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268148 ↗
• MalfunctionFeb 2, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED "THE ADAPTERS ON THE END THAT ATTACH TO THE INSPIRATORY AND EXPIRATORY SIDE ARE NOT TIGHT AND NOT PASSING PRE-USE CHECK". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268059 ↗