Brand Name | HEART START XL |
Type of Device | DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS NORTH AMERICA LLC |
22100 bothell everett highway |
|
bothell WA 98021 |
|
Manufacturer Contact |
tanya
deschmidt
|
22100 bothell everett highway |
bothell, WA 98021
|
9095703538
|
|
MDR Report Key | 19215600 |
MDR Text Key | 341418878 |
Report Number | 3030677-2024-01567 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | PO |
PMA/PMN Number | K021453 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
07/26/2024 |
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 | M4735A |
Device Catalogue Number | M4735A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/18/2024 |
Initial Date FDA Received | 04/30/2024 |
Supplement Dates Manufacturer Received | 06/18/2024 07/16/2024 Not provided
|
Supplement Dates FDA Received | 06/18/2024 07/21/2024 07/26/2024
|
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 |
|
|