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Ultra PC % Package B 36100Recalls & 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 00813830022469), received between Oct 12, 2016 and Oct 12, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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

Device problems

  • Thermal Decomposition of Device1

Patient problems

  • Patient Problem/Medical Problem1

Recent adverse event reports

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

  • MalfunctionOct 12, 2016Thermal Decomposition of Device; Thermal Decomposition of Device

    AN ANESTHESIA GAS-MACHINE FLOWMETER AND 4 CYLINDER PORTABLE SYSTEM WERE IN USE DURING A DENTAL PROCEDURE. THE DENTIST OPERATING THE MACHINE EXPERIENCED INJURIES TO THE HAND WHEN THE O2 REGULATOR PORTION OF THE 4 CYLINDER PORTABLE SYSTEM EXPLODED. NO OTHER PATIENTS OR STAFF MEMBERS WERE AFFECTED BY THIS INCIDENT.

    Patient problems: Patient Problem/Medical Problem

    MAUDE report 6023327 ↗

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.