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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BMC MEDICAL CO., LTD LUNA II AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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BMC MEDICAL CO., LTD LUNA II AUTO; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number LG2A00
Device Problem Particulates (1451)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2023
Event Type  malfunction  
Event Description
React health received a complaint from a durable medical equipment provider that black stuff was reported coming out of a mask.No patient harm or injury was reported.The device has been received by the importer but the manufacturer has not taken possession of the device.A final report will be filed once the manufacturer's investigation is complete.
 
Manufacturer Narrative
This report was previously submitted to the fda as an importer.This was incorrect.This complaint did not contain an allegation of patient death or serious harm or injury but a possible malfunction only.Per title 21, part 803 this report should only be forwarded to the manufacturer.
 
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Brand Name
LUNA II AUTO
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
BMC MEDICAL CO., LTD
room 110 tower a fengyu bldg
no.115 fucheng road
haidian, beijing 10003 6
CH  100036
MDR Report Key18437592
MDR Text Key331822016
Report Number3009096682-2024-00006
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberLG2A00
Device Catalogue NumberLG2A00
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/18/2024
Distributor Facility Aware Date12/05/2023
Device Age2 YR
Event Location Home
Date Report to Manufacturer01/18/2024
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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