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Flowmeter, CM DISS 27514Recalls & reported problems

Accutron, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813830023701), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Convulsion/Seizure1

Recent adverse event reports

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

  • MalfunctionNov 4, 2022Adverse 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 THE PATIENT WENT BLUE AND STARTED SEIZING. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND WAS REPORTED TO HAVE FULLY RECOVERED.

    Patient problems: Convulsion/Seizure

    MAUDE report 15735581 ↗

Other Gas-Machine, Anesthesia devices

All Gas-Machine, Anesthesia devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.