Brand Name | HEARTSTART HOME DEFIBRILLATOR, HS1 |
Type of Device | AED |
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 | 18973781 |
MDR Text Key | 338524909 |
Report Number | 3030677-2024-01107 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
UDI-Device Identifier | 00884838075849 |
UDI-Public | 00884838075849 |
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | P160029 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
06/21/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | M5066A |
Device Catalogue Number | 453564994311 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
03/12/2024 |
Initial Date FDA Received | 03/25/2024 |
Supplement Dates Manufacturer Received | 05/21/2024 06/20/2024
|
Supplement Dates FDA Received | 06/17/2024 06/21/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/01/2023 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
Patient Sex | Female |
|
|