Brand Name | ST8OI STRESS TEST SYSTEM |
Type of Device | PHILIPS ST8OI STRESS TEST SYSTEM |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
robert
corning
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 9828983 |
MDR Text Key | 186135010 |
Report Number | 1218950-2020-01671 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 00884838030299 |
UDI-Public | (01)00884838030299 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K121638 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/03/2020 |
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 |
Health Professional
|
Device Model Number | 860343 |
Device Catalogue Number | 860343 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/03/2020 |
Initial Date FDA Received | 03/13/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/23/2015 |
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 |