Brand Name | HEARTSTART MRX |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman rd. |
andover MA 01810 |
|
Manufacturer Contact |
phyllis
mccarthy
|
3000 minuteman rd. |
andover, MA 01810
|
9786592281
|
|
MDR Report Key | 3773828 |
MDR Text Key | 17949318 |
Report Number | 1218950-2014-01735 |
Device Sequence Number | 1 |
Product Code |
MJK
|
Combination Product (y/n) | N |
Reporter Country Code | MX |
PMA/PMN Number | K031187 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
03/07/2014 |
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 | M3535A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2014
|
Initial Date FDA Received | 03/26/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 12/01/2009 |
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 |
|
|