DRIVEMEDICAL 18080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00822383269917), received between Feb 28, 2023 and Mar 12, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Melted” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMar 12, 2025Missing Information; Missing Information

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY THE END USER WHO STATED THAT THE NEBULIZER CAME WITHOUT INSTRUCTIONS FOR ASSEMBLY OR USE. UPON NEEDING TO USE THE NEBULIZER, THE END USER REPORTED WASTING MINUTES ATTEMPTING TO LOCATE ASSEMBLY INSTRUCTIONS AND PUTTING THE NEBULIZER TOGETHER WITHOUT SUCCESS. THIS RESULTED IN CALLING AN AMBULANCE FOR TRANSPORTATION TO THE HOSPITAL. THE END USER REPORTED SPENDING THE DAY IN THE ER FOR MONITORING AND RECEIVING BREATHING TREATMENTS AND WAS THEN DISCHARGED. THIS IS THE ONLY COMPLAINT FOR THIS PRODUCT WITH THIS ISSUE IN THE PAST THREE YEARS. ATTEMPTS TO GATHER ADDITIONAL INFORMATION ABOUT THE PATIENT'S SOURCE FOR THE PRODUCT OR A SERIAL NUMBER HAVE BEEN UNSUCCESSFUL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 21583690 ↗
• MalfunctionFeb 28, 2023Melted; Overheating of Device; Melted; Overheating of Device

  DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER BY AN END USER, WHO STATED THAT "THEY WERE USING THE UNIT AND THE COMPRESSOR BECAME HOT AND MELTED THE TUBING JUST PAST WHERE THE TUBING CONNECTS TO THE UNIT." 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 16451659 ↗