Brand Name | PAGEWRITER TOUCH CARDIOGRAPH |
Type of Device | PAGEWRITER TC70 CARDIOGRAPH |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
betty
harris
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 6914919 |
MDR Text Key | 88454413 |
Report Number | 1218950-2017-06849 |
Device Sequence Number | 1 |
Product Code |
DPS
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K020708 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
HEALTH PROFESSIONAL,USER FACI |
Reporter Occupation |
HEALTH PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
09/11/2017 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 10/05/2017 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | 860315 |
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 | 09/11/2017 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 07/30/2015 |
Is The Device Single Use? |
No
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|