Brand Name | TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 03 ML SQUEEZE FLUSH, MACRODR |
Type of Device | TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
Manufacturer (Section D) |
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. |
avenida cuarzo no. 250 |
ensenada, b.cfa. 22790 |
MX 22790 |
|
Manufacturer Contact |
michael
visocnik
|
600 n. field dr. |
lake forest, IL 60045
|
2247062300
|
|
MDR Report Key | 17276778 |
MDR Text Key | 318965331 |
Report Number | 9617594-2023-00324 |
Device Sequence Number | 1 |
Product Code |
DRS
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K061573 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
06/09/2023 |
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 Catalogue Number | 01C-42584-05 |
Device Lot Number | 8602207 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/09/2023 |
Initial Date FDA Received | 07/07/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/01/2022 |
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 |
|
|