Brand Name | AUTOPULSE LI-ION BATTERY |
Type of Device | COMPRESSOR, CARDIAC, EXTERNAL |
Manufacturer (Section D) |
ZOLL CIRCULATION INC |
2000 ringwood avenue |
san jose CA 95131 |
|
Manufacturer (Section G) |
ZOLL CIRCULATION INC |
2000 ringwood avenue |
|
san jose CA 95131 |
|
Manufacturer Contact |
kimthoa
nguyen
|
2000 ringwood ave |
san jose, CA 95131
|
4085411030
|
|
MDR Report Key | 9211545 |
MDR Text Key | 163547417 |
Report Number | 3010617000-2019-00946 |
Device Sequence Number | 1 |
Product Code |
DRM
|
UDI-Device Identifier | 00849111001823 |
UDI-Public | 00849111001823 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K112998 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/18/2019 |
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 | 8700-0752-01 |
Device Catalogue Number | 8700-0752-01 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/01/2019 |
Initial Date FDA Received | 10/18/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/11/2018 |
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 |