Brand Name | WORKMATE CLARIS SYSTEM DISPLAY PLUS |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
st. paul MN 55117 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
|
st. paul MN 55117 |
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 11855224 |
MDR Text Key | 251684855 |
Report Number | 2184149-2021-00178 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 05415067001245 |
UDI-Public | 05415067001245 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151911 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
05/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/20/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | H700124 |
Device Catalogue Number | H700124 |
Device Lot Number | 5339992 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/26/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/07/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Removal/Correction Number | 2184149-05/05/21-001-R |
Patient Sequence Number | 1 |