Luna® II Auto CPAP LG2A00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06948538363294), received between Jul 22, 2024 and May 11, 2026 — classified as 1 injury, 1 malfunction.

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.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  BMC RECEIVED RELEVANT COMPLAINT FEEDBACK SUBMITTED BY REACT HEALTH .THE FOLLOWING WAS REPORTED TO 3B MEDICAL,INC.DBA REACT HEALTH BY A PATIENT VIA EMAIL:"TO WHOM IT MAY CONCERN: THE PURPOSE OF THIS CORRESPONDENCE IS TO LET YOU KNOW OF THE PROBLEMS THAT I EXPERIENCED FOR SEVERAL MONTHS, WITHOUT REALIZING THAT I WAS BREATHING TOXIC AIR FROM THE INTERNAL MALFUNCTIONING OF MY CPAP MACHINE. AT THIS TIME, I AM CONTINUING TO EXPERIENCE AND HAVE BEEN FOR SEVERAL MONTHS: ¡¤SHORTNESS OF BREATH ¡¤INTERMITTENT COUGHING ¡¤CHOKING FROM WHICH I HAD TO REMOVE THE MASK AND DISCONTINUE MY TREATMENT ON SEVERAL OCCASIONS. ¡¤HEADACHES I INITIALLY THOUGHT THE MASK WAS CAUSING THESE PROBLEMS. BUT AFTER CHANGING THE MASK A FEW TIMES, THESE SYMPTOMS PERSISTED. BUT AFTER TAKING THE MACHINE BACK TO THE SLEEP CARE CENTER IN MARCH FOR THEM TO LOOK AT, THEY ADVISED ME TO RETURN THE MACHINE TO AEROCARE (ADAPTHEALTH) FOR REPLACEMENT. AT THAT TIME, I FOUND OUT THAT THESE SYMPTOMS RESULTED FROM THE FAILURE OF THE INTERNAL COMPONENTS WHICH WERE SLOWLY BURNING THROUGH THE AIR COMING FROM THE MACHINE. IF THIS CORRESPONDENCE IS A MATTER OF CONCERN TO REACTHEALTH, I WOULD APPRECIATE AN IMMEDIATE RESPONSE." 3B MEDICAL, I

  Patient problems: Choking; Cough; Dyspnea; Headache

  MAUDE report 25134390 ↗
• MalfunctionJul 22, 2024Device Emits Odor; Device Emits Odor

  REACT HEALTH RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT PROVIDER STATING THEIR PATIENT REPORTS A BURNING ODOR WHILE USING THE CPAP. THERE WAS NO PATIENT INJURY OR HARM REPORTED. THE MANUFACTURER HAS RECEIVED THE DEVICE AND INVESTIGATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19791792 ↗