Brand Name | CO-SET PLUS FLOW-TRU HOUSING |
Type of Device | PROBE, THERMODILUTION |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES DR |
parque industrial de itabo |
carr. sanchez km 18.5 |
haiana, san cristobal |
DR |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES DR |
parque industrial de itabo |
carr. sanchez km 18.5 |
haiana |
|
Manufacturer Contact |
samantha
eveleigh
|
1 edwards way |
irvine, CA 92614
|
|
MDR Report Key | 19213290 |
MDR Text Key | 341531973 |
Report Number | 2015691-2024-03227 |
Device Sequence Number | 1 |
Product Code |
KRB
|
UDI-Device Identifier | 07460691949973 |
UDI-Public | (01)07460691949973(17)270605(11)220606(10)64390628 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | K833997 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,User Facility |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/30/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/30/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 93505 |
Device Lot Number | 64390628 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/08/2024 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 06/06/2022 |
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 |
|
|