HAMILTON-BC4022 260186Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630002804189), received between May 25, 2023 and May 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 25, 2023Crack; Fluid/Blood Leak

  HIGH FLOW ADULT HUMIDIFIER CONTAINER HAD A WATER LEAK. THIS IS THE SECOND CONTAINER IN THE LAST COUPLE WEEKS THAT THE REPORTING EMERGENCY MEDICAL TECHNICIAN HAS ENCOUNTERED WITH A WATER LEAK. THIS IS THE SECOND ISSUE OF THE ADULT CIRCUIT BEING CRACKED THAT HAS BEEN BROUGHT TO MY ATTENTION. IN BOTH CASES, NO IMPACT TO PATIENT CARE. BOTH TIMES, THE CIRCUIT WAS IN THE BUBBLE WRAP, AND THE CIRCUITS SHOULD BE SUFFICIENTLY PROTECTED IN THEIR STORAGE. FIRST INCIDENT WAS REPORTED TO A SUPERVISOR. ALSO, CONCERN WAS GIVEN TO THE SUPERVISOR ABOUT ONLY HAVING ONE ADULT HUMIDIFIER CONTAINER IN THE TRUCK WHEN WE CANNOT SWITCH THE CONTAINER. THE FIRST CONTAINER WAS A MINOR LEAK, BUT THE CONTAINER USED TODAY SOAKED A BATH BLANKET. UNFORTUNATELY, NO PICTURES WERE TAKEN, AND THE CREW DID NOT RETURN THE LEAKY CIRCUIT NOR KEEP THE PACKAGING BUT DISCARDED BOTH. ACTION TAKEN IS THAT A SECOND ADULT CIRCUIT WILL BE ADDED TO THE TRUCKS TO PROVIDE A BACKUP. IN FOLLOW UP WITH THE HAMILTON BUSINESS MANAGER WAS TOLD THAT THE ADULT HFNC CIRCUITS LEAKING IS AN ISSUE THAT HAS BEEN REPORTED BACK TO HAMILTON A HANDFUL OF TIMES IN THE LAST YEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001488 ↗