Brand Name | LIFEVEST WCD 4000 SYSTEM |
Type of Device | WEARABLE CARDIOVERTER DEFIBRILLATOR |
Manufacturer (Section D) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
pittsburgh PA 15238 3495 |
|
Manufacturer (Section G) |
ZOLL MANUFACTURING CORPORATION |
121 gamma drive |
|
pittsburgh PA 15238 3495 |
|
Manufacturer Contact |
anna
beatty
|
121 gamma drive |
pittsburgh, PA 15238-3495
|
4129683333
|
|
MDR Report Key | 10676451 |
MDR Text Key | 211351186 |
Report Number | 3008642652-2020-08905 |
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 |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
10/13/2020 |
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 | 09/22/2020 |
Initial Date Manufacturer Received |
09/29/2020
|
Initial Date FDA Received | 10/14/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/25/2015 |
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 |