Drive 18081Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383504131), received between Sep 14, 2022 and Oct 6, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fire” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2022Temperature Problem; Temperature Problem

  DEVILBISS HEALTHCARE RECEIVED A MEDWATCH REPORT REGARDING AN INCIDENT INVOLVING AN OXYGEN CONCENTRATOR, WHICH STATES "PATIENT SMOKING WITH OXYGEN ON AND SUSTAINED SECOND DEGREE BURNS TO FACE." THERE IS NO STATEMENT OR EVIDENCE IN THE REPORT SUGGESTING THE OXYGEN CONCENTRATOR MALFUNCTIONED OR IN ANY WAY CAUSED OR CONTRIBUTED TO THE PATIENT INJURY. THE UNIT WAS RETURNED TO DEVILBISS FOR EVALUATION, AND THE EVIDENCE INDICATES THE ROOT CAUSE OF THE THERMAL DAMAGE TO THE UNIT WAS THE RESULT OF AN EXTERNAL HEAT/FIRE SOURCE, WHICH IS CONSISTENT WITH THE REPORT OF THE PATIENT SMOKING WHILE USING THE OXYGEN CONCENTRATOR. THE UNIT WAS REPAIRED AND IS OPERATING TO SPECIFICATION."

  Patient problems: Sore Throat; Unspecified Infection

  MAUDE report 15550733 ↗
• MalfunctionSep 14, 2022Fire; Fire

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY THE PATIENT, WHO STATED THAT THE "NEBULIZER CAUGHT ON FIRE AND HE IMMEDIATELY PULLED THE POWER CORD AND THREW THE NEBULIZER OUT THE DOOR." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419206 ↗