Brand Name | HEARTSTART MRX 3 WIRE (SNAP) AAMI |
Type of Device | ECG LEAD SET |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
wendy
chadbourne
|
3000 minuteman road |
andover, MA 01810
|
|
MDR Report Key | 4944831 |
MDR Text Key | 17942662 |
Report Number | 1218950-2015-03946 |
Device Sequence Number | 1 |
Product Code |
DPS
|
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,USER FACILITY |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
07/01/2015 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 07/28/2015 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | M3526A |
Device LOT Number | UNKNOWN |
Was Device Available For Evaluation? |
Yes
|
Is The Reporter A Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 07/01/2015 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
|
|