Brand Name | AXIOM SENSIS, HEMO LOW |
Type of Device | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Manufacturer (Section D) |
SIEMENS HEALTHCARE GMBH |
siemenstrasse 1 |
forcheim, 91301 |
GM 91301 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE GMBH |
siemenstrasse 1 |
|
forcheim, 91301 |
GM
91301
|
|
Manufacturer Contact |
meredith
adams
|
40 liberty blvd. |
65-1a |
malvern, PA 19355
|
6104486461
|
|
MDR Report Key | 7337233 |
MDR Text Key | 102314210 |
Report Number | 3004977335-2018-19034 |
Device Sequence Number | 1 |
Product Code |
DQK
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K150493 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Remedial Action |
Inspection |
Type of Report
| Initial,Followup |
Report Date |
02/26/2018 |
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 Model Number | 6634633 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 02/26/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 02/26/2018 |
Initial Date Manufacturer Received |
02/26/2018 |
Initial Date FDA Received | 03/14/2018 |
Supplement Dates Manufacturer Received | 04/11/2018
|
Supplement Dates FDA Received | 04/11/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|