Brand Name | ADVANCED MEMBRANE GAS EXCHANGE PMP STERILE |
Type of Device | OXYGENATOR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
EUROSETS S.R.L. |
strada statale 12, n°143 |
medolla, modena 41036 |
IT 41036 |
|
Manufacturer (Section G) |
EUROSETS S.R.L. |
strada statale 12, n°143 |
|
medolla, modena 41036 |
IT
41036
|
|
Manufacturer Contact |
bob
fryc
|
6035 stoneridge drive |
pleasanton, CA 94588
|
7818528204
|
|
MDR Report Key | 18301467 |
MDR Text Key | 330172180 |
Report Number | 3003752502-2023-02408 |
Device Sequence Number | 1 |
Product Code |
DTZ
|
UDI-Device Identifier | 08034013782020 |
UDI-Public | 08034013782020 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K141492 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/11/2023 |
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 | US5062 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/06/2023 |
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/28/2023
|
Initial Date FDA Received | 12/11/2023 |
Was Device Evaluated by Manufacturer? |
No
|
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 |