MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for LIFEVEST WCD 4000 SYSTEM 10A0988 manufactured by Zoll Manufacturing Corporation.
| Report Number | 3008642652-2020-02569 |
| MDR Report Key | 9889507 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2016-05-12 |
| Date Added to Maude | 2020-03-27 |
| 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 | ELIZA SCHALLY |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 9683333 |
| Manufacturer G1 | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Street | 121 GAMMA DRIVE |
| Manufacturer City | PITTSBURGH, PA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFEVEST WCD 4000 SYSTEM |
| Generic Name | WEARABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | MVK |
| Date Received | 2020-03-27 |
| Model Number | WCD 4000 |
| Catalog Number | 10A0988 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MANUFACTURING CORPORATION |
| Manufacturer Address | 121 GAMMA DRIVE PITTSBURGH, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2020-03-27 |