Luna® G3 CPAP LG3500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06948538365625), received between Jun 4, 2024 and Jul 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (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.

• MalfunctionJul 1, 2024Leak/Splash; Unexpected Shutdown; Leak/Splash; Unexpected Shutdown

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THAT THE MACHINE IS BLOWING WATER STRAIGHT OUT AND CAUSING A CHOKING HAZARD TO THE PATIENT. THE EQUIPMENT PROVIDER ALSO STATED THE DEVICE WAS STOPPING DURING THE NIGHT AND THE PATIENT COULD NOT CATCH THEIR BREATHE. NO PATIENT HARM OR INJURY HAS BEEN REPORTED. THE MANUFACTURER HAS RECEIVED THE DEVICE AND INVESTIGATED.

  Patient problems: Dyspnea

  MAUDE report 19641512 ↗
• MalfunctionJun 4, 2024Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THAT A DEVICE WAS OVERHEATING AND HAD A BURNING SMELL. THERE WAS NO PATIENT HARM OR INJURY REPORTED.THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED ONCE THE INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19465057 ↗