Brand Name | LUNA G3 CPAP |
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 Key | 18318054 |
MDR Text Key | 330377734 |
Report Number | 3009096682-2023-00011 |
Device Sequence Number | 1 |
Product Code |
BZD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
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 |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | LG3500 |
Device Catalogue Number | LG3500 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/18/2024 |
Distributor Facility Aware Date | 11/14/2023 |
Device Age | 2 YR |
Event Location |
Home
|
Date Report to Manufacturer | 01/18/2024 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 12/13/2023 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 01/18/2024
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|