Brand Name | LIFELINE |
Type of Device | AUTOMATED EXTERNAL DEFIBRILLATOR |
Manufacturer (Section D) |
DEFIBTECH, L.L.C. |
741 boston post rd. |
suite 201 |
guilford CT 06437 |
|
Manufacturer (Section G) |
DEFIBTECH, L.L.C. |
14 commercial st. |
|
branford CT 06405 |
|
Manufacturer Contact |
ian
white
|
741 boston post road |
suite 201 |
guilford, CT 06437
|
2034536654
|
|
MDR Report Key | 19051297 |
MDR Text Key | 339491058 |
Report Number | 3003521780-2024-00263 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 10815098020079 |
UDI-Public | 10815098020079 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P160032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/08/2024 |
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 Model Number | DDU-100 |
Initial Date Manufacturer Received |
03/08/2024
|
Initial Date FDA Received | 04/05/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/29/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|