PUREFILL PF1100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814470020020), received between May 31, 2017 and May 31, 2017 — classified as 2 malfunctions.

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

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.

• MalfunctionMay 31, 2017Device Inoperable; Device Inoperable

  A CUSTOMER REPORTED THAT THEIR PUREFILL OXYGEN COMPRESSOR WAS DAMAGED. NO ADVERSE EVENTS OR ISSUES WERE REPORTED. UPON INVESTIGATION OF THE RETURNED UNIT, IT WAS CONFIRMED THAT THE DRIVE BELT WAS LOOSE FROM THE GEARS. AFTER ADDITIONAL TESTING, EVIDENCE OF THERMAL DEGRADATION OF INTERNAL COMPONENTS WAS FOUND WHICH LED TO THE PUREFILI OXYGEN COMPRESSOR FAILING TO FILL THE PORTABLE OXYGEN TANK. THE DEVICE FAILURE WILL RESULT IN A BLINKING YELLOW LED SYSTEM WARNING. THE THERMAL DAMAGE WAS SELFLIMITING AND WAS CONTAINED WITHIN THE PISTON CYLINDER. THIS FAILURE MODE ALSO RESULTS IN THE POTENTIAL FOR CONVEYANCE OF COMBUSTION BY-PRODUCTS TO THE ATTACHED OXYGEN CYLINDER. THE PUREFILL OXYGEN COMPRESSOR WAS RETURNED AND INVESTIGATION RESULTS ARE DOCUMENTED IN THE EVALUATION SUMMARY. OXYGEN CONTAMINATION RISK HAS BEEN SHOWN TO BE MINIMAL TO ZERO BY THIRD PARTY ANALYSIS. WHILE NO ADVERSE EVENTS HAVE OCCURRED AND THE PROBABILITY OF ADVERSE EVENT IN THE EVENT OF A RECURRENCE OF THIS MALFUNCTION IS CONSIDERED VERY REMOTE, REMEDIATE ACTION IS BEING TAKEN IN AN ABUNDANCE OF CAUTION. IN ADDITION, THE MALFUNCTION WOULD NOT BE LIKELY TO CAUSE DEATH OR SERIOUS INJURY IF THEY WERE TO RECUR; HOWEVER, THIS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600772 ↗
• MalfunctionMay 31, 2017Device Inoperable; Device Inoperable

  A CUSTOMER REPORTED LOW OXYGEN LEVELS WITH THEIR PUREFILL OXYGEN COMPRESSOR AND IT WAS INDICATED THAT THE COMPRESSOR COULD NOT FILL THE OXYGEN CYLINDERS. NO ADVERSE EVENTS OR ISSUES WERE REPORTED. UPON INVESTIGATION OF THE RETURNED UNIT, EVIDENCE OF THERMAL DEGRADATION OF INTERNAL COMPONENTS WAS FOUND WHICH FED TO THE PUREFILL OXYGEN COMPRESSOR FAILING TO FILL THE PORTABLE OXYGEN TANK. THE DEVICE FAILURE WILL RESULT IN A BLINKING YELLOW LED SYSTEM WARNING. THE THERMAL DAMAGE WAS SELF-LIMITING AND WAS CONTAINED WITHIN THE PISTON CYLINDER. THIS FAILURE MODE ALSO RESULTS IN THE POTENTIAL FOR CONVEYANCE OF COMBUSTION BY-PRODUCTS TO THE ATTACHED OXYGEN CYLINDER. THE PUREFILL OXYGEN COMPRESSOR WAS RETURNED AND INVESTIGATION RESULTS ARE DOCUMENTED IN THIS REPORT. THE THERMAL EVENT WAS ISOLATED AND FULLY CONTAINED WITHIN THE PISTON CYLINDER. TEST RESULTS DEMONSTRATED THAT DELIVERED COMPRESSED THERAPEUTIC OXYGEN CONTAMINATION RISK WOULD NOT RESULT IN ANY IMMEDIATE OR LONG TERM HEALTH RISKS. WHILE NO ADVERSE EVENTS HAVE OCCURRED AND THE PROBABILITY OF ADVERSE EVENT IN THE EVENT OF A RECURRENCE OF THIS MALFUNCTION IS CONSIDERED VERY REMOTE, REMEDIAL ACTION IS BEING TAKEN IN AN ABUNDANCE OF CA

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600728 ↗