MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for ZEPHYR ENDOBRONCHIAL VALVE ZEPHYR 4.0-LP EBV EBV-TS-4.0-LP manufactured by Pulmonx Corporation.
[180355961]
At the time of this initial report, only very limited information about this event has been obtained. A follow-up report will be submitted after this information has been received.
Patient Sequence No: 1, Text Type: N, H10
[180355962]
On (b)(6) 2020, the patient underwent a bronchoscopic lung volume reduction procedure with zephyr valves (4. 0-lp, 5. 5, 5. 5-lp) and was discharged from the hospital on (b)(6) 2020. Patient passed away in hospice on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007797756-2020-00045 |
| MDR Report Key | 9739284 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-11-11 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LELAND KEYT |
| Manufacturer Street | 700 CHESEAPEAKE DRIVE |
| Manufacturer City | REDWOOD CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2160144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZEPHYR ENDOBRONCHIAL VALVE |
| Generic Name | ENDOBRONCHIAL VALVE |
| Product Code | NJK |
| Date Received | 2020-02-21 |
| Model Number | ZEPHYR 4.0-LP EBV |
| Catalog Number | EBV-TS-4.0-LP |
| Lot Number | 504630-V7.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PULMONX CORPORATION |
| Manufacturer Address | 700 CHESAPEAKE DRIVE REDWOOD CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-02-21 |