Brand Name | SEEQ |
Type of Device | DETECTOR AND ALARM, ARRHYTHMIA |
Manufacturer (Section D) |
EPIC TECHNOLOGIES, LLC |
4240 irwin-simpson road |
mason OH 45040 |
|
Manufacturer (Section G) |
EPIC TECHNOLOGIES, LLC |
4240 irwin-simpson road |
|
mason OH 45040 |
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 7658710 |
MDR Text Key | 113026808 |
Report Number | 3010824444-2018-00006 |
Device Sequence Number | 1 |
Product Code |
DSI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K133701 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
07/03/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Model Number | P01575-010 |
Device Catalogue Number | P01575-010 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
06/20/2018 |
Initial Date FDA Received | 07/03/2018 |
Date Device Manufactured | 02/27/2018 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 55 YR |
|
|