HUDSON RCI IPN049872Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704641410), received between Aug 27, 2021 and Sep 2, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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.

• MalfunctionSep 2, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT: THE AIR CUSHION FACE MASK GOT DETACHED FROM THE BREATHING CIRCUIT BEFORE USE ON A PATIENT. THEREFORE, BOTH THE MASK AND THE BREATHING CIRCUIT WAS REPLACED WITH A NEW UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352479 ↗
• MalfunctionNov 2, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AIR LEAKED FROM THE RESPIRATORY TUBE DURING THE TEST BEFORE USE". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737949 ↗
• MalfunctionAug 27, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BREATHING BAG FOR ANESTHESIA DID NOT INFLATE DURING A PRETEST BEFORE USE. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12381027 ↗
• MalfunctionAug 27, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, "BEFORE USE ON A PATIENT, THE USER WAS UNABLE TO CONNECT THE CONNECTOR TO THE PATIENT-SIDE DEVICE BECAUSE IT WAS TOO HARD. THEREFORE, A NEW UNIT WAS USED INSTEAD". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12380995 ↗