Brand Name | HEARTSTART HOME |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
22100 bothell everett hwy |
bothell WA 98021 |
|
Manufacturer Contact |
tanya
deschmidt
|
22100 bothell everett hwy |
bothell, WA 98021
|
|
MDR Report Key | 8245614 |
MDR Text Key | 133050501 |
Report Number | 3030677-2019-00071 |
Device Sequence Number | 1 |
Product Code |
NSA
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | 020715 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Consumer,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
01/25/2024 |
2 Devices were Involved in the Event: |
1
2
|
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 Model Number | M5068A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/11/2019 |
Initial Date FDA Received | 01/14/2019 |
Supplement Dates Manufacturer Received | 01/11/2019 01/05/2024
|
Supplement Dates FDA Received | 02/20/2019 01/25/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/01/2018 |
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 |
|
|