Brand Name | DIGITRAK XT HOLTER RECORDER |
Type of Device | DIGITRAX XT HOLTER RECORDER |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
nancy
ataide
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 6363859 |
MDR Text Key | 68803316 |
Report Number | 1218950-2017-01354 |
Device Sequence Number | 1 |
Product Code |
MWJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K993617 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
02/07/2017 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 02/28/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | 860322 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Event Location |
No Information
|
Date Manufacturer Received | 02/07/2017 |
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
|
|
|