Brand Name | SWAN-GANZ PACEPORT OXIMETRY |
Type of Device | CATHETER, OXIMETER, FIBER-OPTIC |
Manufacturer (Section D) |
EDWARDS LIFESCIENCES, PR |
state rd indus pk 402 km 1.4 |
anasco PR 00610 |
|
Manufacturer (Section G) |
EDWARDS LIFESCIENCES, PR |
state rd indus pk 402 km 1.4 |
|
anasco PR 00610 |
|
Manufacturer Contact |
jessica
atallah
|
1 edwards way |
irvine, CA 92614
|
9492500294
|
|
MDR Report Key | 15577660 |
MDR Text Key | 306510546 |
Report Number | 2015691-2022-08478 |
Device Sequence Number | 1 |
Product Code |
DQE
|
UDI-Device Identifier | 00690103197341 |
UDI-Public | (01)00690103197341(17)231026(11)211026(10)64014088 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K905458 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/11/2022 |
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 Expiration Date | 10/26/2023 |
Device Model Number | 780F75M |
Device Catalogue Number | 780F75M |
Device Lot Number | 64014088 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/19/2022 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
09/21/2022 |
Initial Date FDA Received | 10/11/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/26/2021 |
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 |