Brand Name | HEARTSTART SLA BATTERY |
Type of Device | DQA, MKJ, LDD, DRO |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman rd. |
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
3000 minuteman rd. |
andover, MA 01810
|
9786597804
|
|
MDR Report Key | 4226336 |
MDR Text Key | 18066987 |
Report Number | 1218950-2014-05142 |
Device Sequence Number | 1 |
Product Code |
DQA
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K001725 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
08/05/2014 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/26/2014 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M3516A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/05/2014 |
Was Device Evaluated by Manufacturer? |
Yes
|
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 |
|
|