Brand Name | AUTOPULSE® LIFEBAND |
Type of Device | CHEST COMPRESSION ASSEMBLY |
Manufacturer (Section D) |
ZOLL CIRCULATION |
2000 ringwood ave, |
san jose CA 95131 |
|
Manufacturer (Section G) |
ZOLL CIRCULATION |
2000 ringwood ave, |
|
san jose CA 95131 |
|
Manufacturer Contact |
kim thoa
nguyen
|
2000 ringwood ave, |
san jose, CA 95131
|
4084192922
|
|
MDR Report Key | 8236451 |
MDR Text Key | 133125164 |
Report Number | 3010617000-2019-00016 |
Device Sequence Number | 1 |
Product Code |
DRM
|
UDI-Device Identifier | 00849111065016 |
UDI-Public | 00849111065016 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K112998 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/10/2019 |
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 |
Health Professional
|
Device Model Number | 8700-0701-03 |
Device Catalogue Number | 8700-0701-03 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/20/2018 |
Initial Date FDA Received | 01/10/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |