Brand Name | POWERHEART G5 KIT, SEMI, UK |
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 | 17558784 |
MDR Text Key | 321474696 |
Report Number | 2112020-2023-00696 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | P160033 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/01/2023 |
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 | G5S-02A |
Device Catalogue Number | G5S-02A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
08/01/2023
|
Initial Date FDA Received | 08/16/2023 |
Supplement Dates Manufacturer Received | 08/01/2023
|
Supplement Dates FDA Received | 09/27/2023
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/07/2017 |
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 |
|
|