MAUDE Adverse Event Report: BMC MEDICAL CO., LTD. LUNA II AUTO CPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Model Number	LG2A00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Headache (1880); Choking (2464); Cough (4457)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
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, inc.[3b] has made multiple unsuccessful attempts, both via phone and in writing, to contact the patient in order to obtain additional information regarding this event.3b also contacted the patient's dme for additional information.The dme advised 3b that they provided the patient with a replacement device, however, the patient refused to return the device listed in this medwatch report.The current disposition of the device is not known.The patient did not provide the dme with any further specifics regarding his allegations, nor did he state whether or not he had sought medical attention for his symptoms.The device has not been returned to 3b for an evaluation.The cause of the patient's alleged symptoms could not be determined.3b is reporting this event out of an abundance of caution, as no specific allegation of a device malfunction has been made.

• Brand Name: LUNA II AUTO CPAP
• Common Device Name: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): BMC MEDICAL CO., LTD.; room 10, 17f, building 4,; huiya plaza, no.16 lize road; beijing, fengtai district CN 1 0007; CH CN 100073
• Manufacturer (Section G): BMC (TIANJIN) MEDICAL CO., LTD; 2/f north area and 3/f; blg no.4,no.1 xinxing road; wuqing district, tianjin CN 3 0179; CH CN 301799
• Manufacturer Contact: ning xu ; building c20,; venture headquarters base, no.18 fuyuan street; wuqing district, tianjin CN 3-0179 ; CH CN 301799
• MDR Report Key: 25134390
• Report Number: 3008566132-2026-00004
• Device Sequence Number: 21195531
• Product Code: BZD
• UDI-Device Identifier: 06948538363294
• UDI-Public: (01)06948538363294(11)220505
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K153387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: LG2A00
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 93 KG