Drive 18302GMNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383283210), received between Jul 24, 2024 and Jul 24, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (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

Recent adverse event reports

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

• InjuryJul 24, 2024Use of Device Problem; Use of Device Problem

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A REGULATOR BY A LETTER FROM AN ATTORNEY, WHICH STATES THE END USER WAS REFILLING AN OXYGEN TANK ON WHICH THE REGULATOR WAS PLACED, WHEN LEAKING OXYGEN CAUSED A FIRE TO TEMPORARILY IGNITE AND THE END USER TO SUSTAIN 3RD DEGREE BURNS TO HER LEFT HAND. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT THROUGH PARTICIPATION IN A LAWSUIT. NO SPECIFIC DEFECT IN THE REGULATOR HAS BEEN IDENTIFIED. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 19818545 ↗