Brand Name | LIFEVEST WCD 4000 SYSTEM |
Type of Device | WEARABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
pittsburgh, pa |
|
Manufacturer (Section G) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
|
pittsburgh, pa |
|
Manufacturer Contact |
eliza
schally
|
121 gamma drive |
pittsburgh, pa
|
9683333
|
|
MDR Report Key | 10433780 |
MDR Text Key | 204178428 |
Report Number | 3008642652-2020-07284 |
Device Sequence Number | 1 |
Product Code |
MVK
|
UDI-Device Identifier | 00855778005012 |
UDI-Public | 00855778005012 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P010030 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/20/2020 |
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 | WCD 4000 |
Device Catalogue Number | 10A0987 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/03/2020 |
Initial Date Manufacturer Received |
08/13/2020 |
Initial Date FDA Received | 08/20/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/28/2012 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |