Brand Name | AUTOPULSE® RESUSCITATION MODEL 100 |
Type of Device | CARDIAC CHEST COMPRESSOR |
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 |
kimthoa
sackrison
|
2000 ringwood ave. |
san jose, CA 95131
|
|
MDR Report Key | 19198687 |
MDR Text Key | 341259400 |
Report Number | 3010617000-2024-00376 |
Device Sequence Number | 1 |
Product Code |
DRM
|
UDI-Device Identifier | 00849111001076 |
UDI-Public | 00849111001076 |
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K112998 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
04/26/2024 |
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 | MODEL 100 |
Device Catalogue Number | 8700-0740-16 |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
04/04/2024
|
Initial Date FDA Received | 04/26/2024 |
Was Device Evaluated by Manufacturer? |
No
|
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 |