Ultra DC Flowmeter 31980Recalls & reported problems
Accutron, Inc. · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00813830021219), received between Apr 25, 2024 and Apr 3, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Vomiting2
- Headache1
- Nausea1
- Sleepiness/Drowsiness/Somnolence1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2026Insufficient Device Problem Information
PEDIATRIC PATIENT WAS UNABLE TO WAKE UP AFTER PROCEDURE. EMERGENCY SERVICES WERE CALLED BUT PATIENT WOKE UP BEFORE THEIR ARRIVAL. PATIENT IS FINE NOW.
Patient problems: Sleepiness/Drowsiness/Somnolence
MAUDE report 24781789 ↗InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISTRIBUTOR REPORTED THAT THE UNIT IS GIVING TOO MUCH NITROUS AND MAKING PATIENTS SICK.
Patient problems: Nausea
MAUDE report 22748705 ↗InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
USER FACILITY REPORTED TO (B)(6) THAT DURING TWO PROCEDURES, PATIENTS WERE ON N20 / O2 LESS THAN 10 MINUTES BEFORE VOMITING. STAFF IN THE ROOM WERE GETTING HEADACHES.
Patient problems: Headache; Vomiting
MAUDE report 21039653 ↗MalfunctionApr 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT DURING TWO PATIENT PROCEDURES INVOLVING THE ULTRA DC FLOWMETER THE PATIENTS BECAME "NAUSEOUS" AND "UNRESPONSIVE". THE PATIENTS WERE DISCHARGED AND REPORTED TO BE FINE.
Patient problems: Vomiting
MAUDE report 19182230 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.