Flow sensor 155500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630002801362), received between Apr 10, 2024 and Sep 4, 2024 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Crack; Crack

  THE FOLLOWING WAS REPORTED TO HAMILTON MEDICAL AG: - HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "HOSPITAL STAFF WAS ASSEMBLING A BREATHING CIRCUIT SET FOR USE ON A PATIENT. WHEN HE TOOK A NEW FLOW SENSOR OUT OF THE BOX, HE NOTICED THAT THE FLOW SENSOR HAD A CRACK." - THERE IS NO PATIENT INVOLVEMENT REPORTED. - THERE IS NO NEED FOR ANY MEDICAL INTERVENTION REPORTED. - NEITHER DELAY IN TREATMENT NOR HARM TO THE PATIENT, USER OR THIRD PARTY HAS BEEN REPORTED. THE INVESTIGATION IS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134687 ↗
• MalfunctionApr 10, 2024Crack; Crack

  THE FOLLOWING WAS REPORTED TO HAMITON MEDICAL AG: CUSTOMER REPORTS:- WE'VE HAD AN ISSUES WITH THE NEO FLOW SENSORS USED ON OUR G5'S IN CICU OVER THE WEEKEND. A COUPLE HAVE SPLIT IN THE SAME POSITION AFTER A SHORT PERIOD OF TIME, WHICH AFFECTED THE VENTED PATIENTS. AFFECT ON PATIENT IS UNKNOWN. NO FURTHER INFORMATION RECEIVED SO FAR. NO PATIENT HARM OR CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080543 ↗