Brand Name | 5 LEAD SET SNAP AAMI, ICU |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
hewlett-packard str.2 |
boeblingen 71034 |
GM 71034 |
|
Manufacturer Contact |
kelly
rector
|
3000 minuteman rd |
andover, MA 01810
|
9786592590
|
|
MDR Report Key | 3844739 |
MDR Text Key | 4614217 |
Report Number | 9610816-2014-00067 |
Device Sequence Number | 1 |
Product Code |
DSA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K020531 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Paramedic
|
Type of Report
| Initial |
Report Date |
02/28/2014 |
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 |
Other
|
Device Model Number | M1644A |
Device Lot Number | 2012-04 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/28/2014 |
Initial Date FDA Received | 03/12/2014 |
Was Device Evaluated by Manufacturer? |
No
|
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 |
|
|