BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUNA G3 APAP

    MDR report key: 24212268 · Received January 29, 2026

    Report

    Report Number
    3009096682-2026-00001
    Event Type
    Death
    Date Received
    January 29, 2026
    Date of Event
    December 28, 2025
    Report Date
    February 26, 2026
    Manufacturer
    BMC MEDICAL CO., LTD
    Product Code
    BZD
    UDI-DI
    06948538363331
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT A PATIENT HAD PASSED AWAY WHILE USING A LUNA G3 APAP DEVICE. THE DME HAD BEEN CONTACTED BY THE PATIENT'S REHABILITATION FACILITY REQUESTING ASSISTANCE WITH OBTAINING THE DEVICE¿S ELECTRONIC DATA FOR REVIEW AS PART OF THEIR INVESTIGATION. ACCORDING TO THE DME, THE PATIENT HAD BEEN USING THIS DEVICE FOR ABOUT A YEAR, ALONG WITH A RESMED AIRFIT F20 FULL FACE MASK (LARGE). THE PATIENT WAS NOT USING THE CPAP AS A LIFE-SUPPORTING DEVICE. ON THE DAY THAT THE PATIENT PASSED AWAY, THE FACILITY ADVISED THAT THERE WERE NO ABNORMALITIES AS FAR AS TREATMENTS, MEDICATION ADMINISTRATION, NOR WERE THERE ANY ABNORMAL MANIFESTATIONS OF HIS PHYSICAL SYMPTOMS. THE REHABILITATION FACILITY CONFIRMED THAT THE MASK WAS ON THE PATIENT ON THE NIGHT OF (B)(6) 2025 AND INTO THE MORNING OF (B)(6) 2025, HOWEVER THE FACILITY COULD NOT CONFIRM WHETHER OR NOT THE DEVICE WAS POWERED ON. THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL FOR TREATMENT. EMS WAS CONTACTED AND THEY PRONOUNCED HIS DEATH AT THE FACILITY. THE DME DOWNLOADED THE DEVICE¿S SD CARD AND PROVIDED THE RESULTS TO 3B, WHO IN TURN PROVIDED THE INFORMATION TO THE DEVICE MANUFACTURER FOR ANALYSIS. 3B AND THE MANUFACTURER WERE ALSO ABLE TO DOWNLOAD THE DEVICE'S DATA FROM REACT HEALTH CONNECT AND CONFIRMED THAT THE DATA SETS MATCHED. UPON REVIEW OF THE DATA, IT WAS DETERMINED THAT THE DEVICE WAS LAST USED ON (B)(6) 2025 ¿ TWO DAYS PRIOR TO THE PATIENT¿S DEATH. IT WAS CONFIRMED THAT THE DEVICE WAS NOT POWERED ON AND IN USE WHEN THE PATIENT DIED. THE FACILITY¿S DIRECTOR OF NURSING LATER ADVISED 3B THAT THE INCIDENT IS STILL UNDER INVESTIGATION. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Description of Event or Problem · 0

    INFORMATION FROM THE INITIAL MEDWATCH REPORT ¿ 3B MEDICAL, INC. DBA REACT HEALTH WAS CONTACTED BY A DURABLE MEDICAL EQUIPMENT (DME) PROVIDER ADVISING THAT A PATIENT HAD PASSED AWAY WHILE USING A LUNA G3 APAP DEVICE. THE DME HAD BEEN CONTACTED BY THE PATIENT'S REHABILITATION FACILITY REQUESTING ASSISTANCE WITH OBTAINING THE DEVICE¿S ELECTRONIC DATA FOR REVIEW AS PART OF THEIR INVESTIGATION. ACCORDING TO THE DME, THE PATIENT HAD BEEN USING THIS DEVICE FOR ABOUT A YEAR, ALONG WITH A RESMED AIRFIT F20 FULL FACE MASK (LARGE). THE PATIENT WAS NOT USING THE CPAP AS A LIFE-SUPPORTING DEVICE. ON THE DAY THAT THE PATIENT PASSED AWAY, THE FACILITY ADVISED THAT THERE WERE NO ABNORMALITIES AS FAR AS TREATMENTS, MEDICATION ADMINISTRATION, NOR WERE THERE ANY ABNORMAL MANIFESTATIONS OF HIS PHYSICAL SYMPTOMS. THE REHABILITATION FACILITY CONFIRMED THAT THE MASK WAS ON THE PATIENT ON THE NIGHT OF (B)(6) 2025 AND INTO THE MORNING OF (B)(6) 2025, HOWEVER THE FACILITY COULD NOT CONFIRM WHETHER OR NOT THE DEVICE WAS POWERED ON. THE PATIENT WAS NOT TRANSPORTED TO THE HOSPITAL FOR TREATMENT. EMS WAS CONTACTED AND THEY PRONOUNCED HIS DEATH AT THE FACILITY. THE DME DOWNLOADED THE DEVICE¿S SD CARD AND PROVIDED THE RESULTS TO 3B, WHO IN TURN PROVIDED THE INFORMATION TO THE DEVICE MANUFACTURER FOR ANALYSIS. 3B AND THE MANUFACTURER WERE ALSO ABLE TO DOWNLOAD THE DEVICE'S DATA FROM REACT HEALTH CONNECT AND CONFIRMED THAT THE DATA SETS MATCHED. UPON REVIEW OF THE DATA, IT WAS DETERMINED THAT THE DEVICE WAS LAST USED ON (B)(6) 2025 ¿ TWO DAYS PRIOR TO THE PATIENT¿S DEATH. IT WAS CONFIRMED THAT THE DEVICE WAS NOT POWERED ON AND IN USE WHEN THE PATIENT DIED. THE FACILITY¿S DIRECTOR OF NURSING LATER ADVISED 3B THAT THE INCIDENT IS STILL UNDER INVESTIGATION. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56. NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT 001 ¿ F10: THE DEVICE WAS RETURNED TO THE MANUFACTURER, BMC MEDICAL CO., LTD (¿BMC¿), FOR AN EVALUATION. BMC ADVISED 3B MEDICAL, INC. (DBA REACT HEALTH) THAT THE DEVICE WAS FOUND TO MEET SPECIFICATIONS. NO ABNORMALITIES WERE OBSERVED. THE DEVICE¿S ELECTRONIC RECORDS WERE FURTHER ANALYZED. BMC NOTED THAT THE DEVICE WAS LAST USED LAST USED AT 23:02:14 ON (B)(6) 2025. AFTER OPERATING FOR ONLY 19 SECONDS, IT WAS MANUALLY POWERED OFF AND WAS NEVER ACTIVATED AGAIN FOR TREATMENT. BMC CONFIRMED THAT THE DEVICE'S SD CARD DATA WAS CONSISTENT WITH THE DEVICE¿S ONBOARD STORAGE DATA. THE EVIDENCE SUPPORTS THAT THE DEVICE WAS NOT POWERED ON AND IN USE AT THE TIME OF THE PATIENT¿S DEATH. BMC PERFORMED A REVIEW OF THE DEVICE'S MANUFACTURING RECORDS WHICH SHOWED ALL REQUIREMENTS WERE MET. FINAL TEST SPECIFICATIONS WERE ACCEPTABLE. NO NON-CONFORMITIES OR ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT WHEN REVIEWING THE DEVICE HISTORY RECORD. TREND ANALYSIS AND RISK ANALYSIS WERE CONSIDERED ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION, BMC BELIEVES THAT THE PATIENT'S PASSING IN THE REPORTED EVENT IS UNRELATED TO THE DEVICE. THE CAUSE OF THE PATIENT¿S DEATH COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567526 LUNA G3 APAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD BMC MEDICAL CO., LTD LG3600 06948538363331

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Death