Brand Name | QUANTIEN |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
one st. jude medical drive |
st. paul MN 55117 |
|
MDR Report Key | 8369581 |
MDR Text Key | 137126284 |
Report Number | 2184149-2019-00020 |
Device Sequence Number | 1 |
Product Code |
DQK
|
UDI-Device Identifier | 05415067000996 |
UDI-Public | 05415067000996 |
Combination Product (y/n) | N |
PMA/PMN Number | K123984 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup |
Report Date |
06/17/2019 |
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 | C12787 |
Device Lot Number | 9999999999 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/29/2019 |
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/07/2019
|
Initial Date FDA Received | 02/26/2019 |
Supplement Dates Manufacturer Received | 05/30/2019
|
Supplement Dates FDA Received | 06/17/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|