DeVilbiss iFill 535IRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304000860), received between Dec 2, 2016 and Dec 2, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Maintenance Does Not Comply To Manufacturers Recommendations” (1 report).

1 other recall cover devices cleared under the same FDA submission (K053240); they may or may not involve this specific model.

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.

• MalfunctionDec 2, 2016Maintenance Does Not Comply To Manufacturers Recommendations; Maintenance Does Not Comply To Manufacturers Recommendations

  THE COMPLAINT WAS REPORTED FROM A LONG TERM CARE FACILITY IN FRANCE. THERE IS NO ADVERSE EVENT OR INJURY ASSOCIATED WITH THE COMPLAINT. A NURSE WAS REMOVING/DISCONNECTING A FULL IFILL OXYGEN CYLINDER FROM THE IFILL OXYGEN TRANSFILL UNIT, AT WHICH TIME SHE HEARD A LOUD SOUND AND SAW A BRIEF FLAME COMING FROM THE OXYGEN CONNECTING PORT. THE NURSE IS UNSURE IF THE IFILL UNIT WAS RUNNING OR HAD STOPPED AT THE TIME SHE DISCONNECTED CYLINDER BUT IT NOTED THE IFILL UNIT WAS PLUGGED INTO THE WALL. THE NURSE STATED SHE HEARD A LOUD SOUND AND SAW A BRIEF FLAME, WHICH CAUSED THE NURSE TO DROP THE CYLINDER TO THE FLOOR. ONCE THE CYLINDER WAS ON THE FLOOR THE EVENT ENDED; SHE REPORTED NO OTHER ISSUES WITH THE CYLINDER OR THE IFILL UNIT. THE CYLINDER AND TRANSFILL DEVICE WERE QUARANTINED AND THE OXYGEN SUPPLIER CONTACTED. THE FACILITY ACKNOWLEDGES THE ROUTINE USE OF CLEANING AGENT ON THE IFILL CYLINDER THAT CONTAINS HIGH CONCENTRATIONS OF PROPRANOLOL AND ETHANOL. THE CLEANING AGENT IS HIGHLY FLAMMABLE AND IS CONTRAINDICATED FOR USE WITH OXYGEN EQUIPMENT. THERE WERE NO INJURIES OR DAMAGE RELATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6142736 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053240. One submission often covers many models, so check the product and lot details in each record.

• Z-0038-2007 · Aug 24, 2006 · Terminated
  DeVilbiss iFill Personal Oxygen Station model number 535D.