Brand Name | SWAN GANZ CATHETER |
Type of Device | CATHETER, OXIMETER, FIBER-OPTIC |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES PR |
state rd indus pk 402 km 1.4 |
anasco 00610 |
* 00610 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES PR |
state rd indus pk 402 km 1.4 |
|
anasco 00610 |
*
00610
|
|
Manufacturer Contact |
jessica
atallah
|
1 edwards way |
irvine, CA 92614
|
|
MDR Report Key | 13460170 |
MDR Text Key | 286263295 |
Report Number | 2015691-2022-03802 |
Device Sequence Number | 1 |
Product Code |
DQE
|
UDI-Device Identifier | 00690103003031 |
UDI-Public | (01)00690103003031(17)230818(11)210818(10)63915199;(01)50690103003036(17)230818(11)210818(10)63915199 |
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/04/2022 |
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 Expiration Date | 08/18/2023 |
Device Model Number | 831F75 |
Device Catalogue Number | 831F75P |
Device Lot Number | 63915199 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/14/2022
|
Initial Date FDA Received | 02/04/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/22/2021 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|