Brand Name | UNKNOWN_MEDICAL - BELFAST_PRODUCT |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATOR |
Manufacturer (Section D) |
HEARTSINE TECHNOLOGIES LTD |
203 airport road west |
belfast BT3 9 ED |
EI BT3 9ED |
|
Manufacturer (Section G) |
HEARTSINE TECHNOLOGIES LTD |
203 airport road west |
|
belfast BT3 9 ED |
EI
BT3 9ED
|
|
Manufacturer Contact |
rebecca
funston
|
203 airport road west |
belfast BT3 9-ED
|
EI
BT3 9ED
|
2890939400
|
|
MDR Report Key | 11442364 |
MDR Text Key | 240331257 |
Report Number | 3004123209-2021-00087 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K014067 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/09/2021 |
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 |
No Information
|
Device Catalogue Number | UNK_BEL |
Was Device Available for Evaluation? |
Yes
|
Initial Date Manufacturer Received |
03/01/2021 |
Initial Date FDA Received | 03/09/2021 |
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 |
Initial
|
Removal/Correction Number | Z-0124-2013 |
Patient Sequence Number | 1 |