FDA Adverse Event Malfunction Summary report: N

LUNA G3 BI-PAP MACHINE

MDR report key: 23976450 · Received January 6, 2026

Report

Report Number
MW5181825
Event Type
Malfunction
Date Received
January 6, 2026
Date of Event
November 15, 2025
Report Date
December 30, 2025
Manufacturer
3B MEDICAL INC
Product Code
BZD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I RECEIVED A LUNA G3 BI-PAP MACHINE IN (B)(6) TO REPLACE MY PREVIOUS MACHINE THAT DEVELOPED THE SAME PROBLEM. THE LUNA G3 STARTED BLOWING TOO HIGH OF AIR PRESSURE IN LESS THAN 6 MONTHS. DURING THE NIGHT AFTER I WOULD GO TO SLEEP IT WOULD START BLOWING MORE AIR THAN IT WAS SUPPOSED TO, SO MUCH THAT I WOULD WAKE UP WITH DROOL BEING BLOWN OUT OF THE CORNERS OF MY MOUTH SOMETIMES MY TEE SHIRT WOULD BE WET ON THE NECK. MY AHI WOULD BE UP IN THE 20'S, OTHER TIMES IN THE TEENS. IT TOOK ME AWHILE TO DETERMINE WHAT THE PROBLEM WAS, AND I SWITCHED TO A BI-PAP MACHINE I RECEIVED BEFORE MY LAST TWO BI-PAP MACHINES. I HAVE BEEN USING A BI-PAP MACHINE SINCE THE EARLY OR MID 1990'S, I HAVE HAD SEVERAL MACHINES DURING THIS TIME, ONLY THE LAST TWO DEVELOPED THE PROBLEM OF PRODUCING TO MUCH AIR PRESSURE. I RETURNED THE PREVIOUS MACHINE TO MY DURABLE MEDICAL SUPPLY COMPANY (B)(4) IN (B)(6), SO I DON'T HAVE THE INFORMATION ON IT, OTHER THAN IT WORKED FOR AB5 YEARS. THE LUNA G3, WORKED CORRECTLY FOR LESS THAN 6 MONTHS AS BEST I COULD DIAGNOSE. AFTER TRYING A NEW HEADGEAR MULTIPLE MASK, I GOT THE BI-PAP MACHINE OUT THAT I RECEIVED BEFORE THE LAST TWO. MY AHI WENT BACK DOWN TO LESS THAN 5 THE FIRST NIGHT. THE HIGHEST IT'S BEEN THE PAST WEEK THAT I HAVE BEEN USING THE OLD BI-PAP MACHINE IS 6 AHI. MY AHI AVERAGE FOR THE PREVIOUS 24 DAYS, (B)(6), IS 16.8. SOME NIGHTS WERE HIGHER SOME WAS LOWER IN ORDER TO HAVE THE AVERAGE OF 16.8. EVERY NIGHT A BI-PAP USER HAS SUCH HIGHER-THAN-NORMAL READINGS, MEANS A DAY OF NOT FILLING THEIR BEST, FILLING SLEEPY AND TIRED. IF THIS IS A COMMON PROBLEM THAT HAS COME UP WITH THE MANUFACTURERS OF THESE MACHINES, I WISH THAT YOU WOULD TAKE SWIFT ACTION TO CORRECT IT. I THINK IT IS ODD THAT ONE PERSON WOULD HAVE THE SAME PROBLEM WITH TWO DIFFERENT BI-PAP MACHINES. THANK YOU FOR LOOKING INTO TO THE CONSUMER COMPLAINTS, HELPING TO PROTECT THE CONSUMERS. I MUST RETURN THE MACHINE TO (B)(6) IN (B)(6) IN ORDER TO GET ANOTHER MACHINE OR REPAIRS DONE, THEY ARE THE ONES I TURNED IN MY PREVIOUS MACHINE IN I BELIEVE (B)(6) 2025. PT CODE: 4582. DEVICE CODE: 2954. REF REPORT: MW5181824.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
47824 LUNA G3 BI-PAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD 3B MEDICAL INC G3 A20

Patients

Seq Age Sex Outcome Treatment
1 79 YR Male Other (DOCUSATES SENNOSIDES LAXITIVES).| 81 MG ASPRIN.| BI-PAP MACHINE.| CLONAZEPAM.| ELECTRIC WHEELCHAIR. | MIRAPEX.| MOUNJARO.| NEURONTIN.| OXYCODONE. | PRAVASTIN SODIUM.| PROPRANOLOL.| PROVIGIL.| SINEMET.| VIT. D.| WELBUTRIN XL.| ZANAFLEX.