DeVilbiss 125DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885304022237), received between Apr 15, 2024 and Sep 3, 2026 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fire” (2 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Apr 11, 2025Open, Classified

   Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing.

   Z-1727-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Sep 19, 2022Open, Classified

   An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

   Z-0229-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathSep 3, 2026Fire

  Drive Medical was notified of an incident involving an oxygen concentrator from a device provider's attorney regarding a concentrator allegedly causing house fire and subsequent death. Drive Medical is currently investigating the incident, including attempting to inspect the device. An update will be filed if additional information becomes available.

  Patient problems: Burn(s)

  MAUDE report 50586238 ↗
• InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PORTABLE OXYGEN CONCENTRATOR BY THE HOME OXYGEN PROVIDER WHO STATED THAT THE "PATIENT STATED SHE WAS IN A PERSONAL TRUCK AND WENT TO GET OUT AND HAD A SEIZURE AND FELL OUT." THERE WERE NO OTHER INJURIES ASSOCIATED WITH THE REPORTED INCIDENT. THE PATIENT TOLD THE PROVIDER THAT SHE SOUGHT MEDICAL ATTENTION, AND CLAIMS A PHYSICIAN ADVISED HER "SHE HAS A BROWN SPOT ON HER BRAIN." THE PATIENT IS CONCERNED THE PORTABLE CONCENTRATOR MAY HAVE CONTRIBUTED TO THE EVENT. DEVILBISS HEALTHCARE HAS NOT RECEIVED A REPORT FROM THE PATIENT'S PHYSICIAN. DEVILBISS HEALTHCARE IS REQUESTING THE RETURN OF THE DEVICE FOR INSPECTION AND WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: Brain Injury; Convulsion/Seizure

  MAUDE report 23423621 ↗
• MalfunctionApr 15, 2024Fire; Fire

  DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A PORTABLE OXYGEN CONCENTRATOR DC CHARGER THAT REPORTEDLY BECAME VERY HOT, STARTED SMOKING AND CAUGHT FIRE AND BURNED A HOLE IN THE LEATHER SEAT OF THE END USER'S CAR. THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING RETRIEVING THE DEVICE FOR EVALUATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112303 ↗