Brand Name | HEARTSTART MRX -EMS DEFIBRILLATOR |
Type of Device | DEFIBRILLATOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
robert
corning
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 6515339 |
MDR Text Key | 73496905 |
Report Number | 1218950-2017-02652 |
Device Sequence Number | 1 |
Product Code |
MKJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K031187 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
04/04/2017 |
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 | M3536A |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/30/2017 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/04/2017 |
Initial Date FDA Received | 04/24/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 06/05/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 02/27/2007 |
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 |
|
|