Ultra PC% Flowmeter 31975Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00813830021158), received between Jan 12, 2023 and Feb 7, 2025 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT 2 PATIENTS GOT SICK AT 40% FLOW AND DR. WAS CONCERNED ABOUT METER FLOWING ACCURATELY.

  Patient problems: Nausea

  MAUDE report 21332938 ↗
• MalfunctionNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING PATIENT PROCEDURES INVOLVING THE ULTRA PC % FLOWMETER, THREE PATIENTS WOKE UP AND BEGAN TO VOMIT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Vomiting

  MAUDE report 18049724 ↗
• MalfunctionJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE INVOLVING THE ULTRA PC% FLOWMETER WHILE NITROUS OXIDE WAS ADMINISTERED THE PATIENT APPEARED OVERLY SEDATED AND EXCITED. THE PATIENT WAS ADMINISTERED 100% OXYGEN AND FULLY RECOVERED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Oversedation

  MAUDE report 16147857 ↗