Brand Name | HEARTSTART HOME |
Type of Device | AED |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
22100 bothell everett hwy |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS HEALTHCARE - BOTHELL |
22100 bothell-everett hwy |
bldg a |
bothell WA 98021 |
|
Manufacturer Contact |
dana
tackett
|
22100 bothell everett hwy |
bothell, WA 98021
|
|
MDR Report Key | 8424152 |
MDR Text Key | 138946431 |
Report Number | 3030677-2019-00527 |
Device Sequence Number | 1 |
Product Code |
NSA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K040904 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
02/19/2019 |
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 |
Other
|
Device Expiration Date | 09/30/2014 |
Device Model Number | M5068A |
Device Lot Number | Y021512-03 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/19/2019
|
Initial Date FDA Received | 03/15/2019 |
Supplement Dates Manufacturer Received | 02/19/2019
|
Supplement Dates FDA Received | 03/18/2019
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 04/01/2012 |
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 |
|
|