Brand Name | HEART START XL |
Type of Device | DEFIBRILLATOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
22100 bothell everett hwy |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
daniel
derochers
|
22100 bothell everett hwy |
bothell, WA 98021
|
|
MDR Report Key | 11293893 |
MDR Text Key | 232047224 |
Report Number | 3030677-2021-00274 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | TH |
PMA/PMN Number | K001725 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/19/2021 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 02/08/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | M4735A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 01/19/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/30/2010 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
|
|