Brand Name | G3 PLUS AUTO, AED, AHA 2010, US ENGLISH |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATOR |
Manufacturer (Section D) |
CARDIAC SCIENCE CORPORATION |
500 burdick parkway |
deerfield WI 53531 9692 |
|
Manufacturer Contact |
scott
august
|
269 mill road |
chelmsford, MA 01824
|
9784219552
|
|
MDR Report Key | 17844814 |
MDR Text Key | 324606006 |
Report Number | 2112020-2023-00827 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00812394021079 |
UDI-Public | 00812394021079 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P160033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
09/08/2023 |
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 |
Other
|
Device Model Number | 9390A-1001 |
Device Catalogue Number | 9390A-1001 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/07/2023 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/08/2023
|
Initial Date FDA Received | 09/29/2023 |
Supplement Dates Manufacturer Received | 09/08/2023
|
Supplement Dates FDA Received | 10/04/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/21/2020 |
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 |
|
|