Brand Name | MEDEX LOGICAL PRESSURE MONITORING SYSTEM |
Type of Device | DRS-TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR |
Manufacturer (Section D) |
SMITHS MEDICAL CZECH REPUBLIC A.S. |
hranice |
EZ |
|
Manufacturer (Section G) |
SMITHS MEDICAL CZECH REPUBLIC A.S. |
olomoucka 306 |
hranice 1 - mesto |
hranice 753 01 |
EZ
753 01
|
|
Manufacturer Contact |
michele
seliga
|
1265 grey fox rd. |
st. paul, MN 55112
|
6516287604
|
|
MDR Report Key | 4795871 |
MDR Text Key | 5856372 |
Report Number | 2183502-2015-00363 |
Device Sequence Number | 1 |
Product Code |
BYX
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Pharmacist
|
Type of Report
| Initial |
Report Date |
05/22/2015 |
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 Operator |
Health Professional
|
Device Catalogue Number | MX9604CZ |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/22/2015 |
Distributor Facility Aware Date | 04/20/2015 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
04/29/2015
|
Initial Date FDA Received | 05/22/2015 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |