Brand Name | ZEPHYR ENDOBRONCHIAL VALVE (EBV) |
Type of Device | ENDOBRONCHIAL VALVE |
Manufacturer (Section D) |
PULMONX CORPORATION |
700 chesapeake drive |
redwood city CA 94063 |
|
Manufacturer Contact |
mahtab
fatemi
|
700 chesapeake drive |
redwood city, CA 94063
|
6504072823
|
|
MDR Report Key | 13671265 |
MDR Text Key | 286637697 |
Report Number | 3007797756-2022-00049 |
Device Sequence Number | 1 |
Product Code |
NJK
|
UDI-Device Identifier | 00811907030119 |
UDI-Public | (01)00811907030119(10)505263V70(17)221105 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P180002 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Study,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial,Followup |
Report Date |
05/05/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/04/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/05/2022 |
Device Model Number | ZEPHYR 4.0 EBV |
Device Catalogue Number | EBV-TS-4.0 |
Device Lot Number | 505263-V7.0 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 02/07/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/05/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
Hospitalization;
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Male |