Brand Name | ADVIA 560 HEMATOLOGY SYSTEM |
Type of Device | ADVIA 560 HEMATOLOGY SYSTEM |
Manufacturer (Section D) |
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
511 benedict ave. |
tarrytown NY 10591 |
|
Manufacturer (Section G) |
DIATRON MI PIC |
registration #: 3009297077 |
tablas str. 39 |
budapest, H-109 7 |
HU
H-1097
|
|
Manufacturer Contact |
christopher
aebig
|
511 benedict ave. |
tarrytown, NY 10591
|
9144153450
|
|
MDR Report Key | 15685654 |
MDR Text Key | 307169473 |
Report Number | 2432235-2022-00292 |
Device Sequence Number | 1 |
Product Code |
GKZ
|
UDI-Device Identifier | 00630414601816 |
UDI-Public | 00630414601816 |
Combination Product (y/n) | N |
Reporter Country Code | CI |
PMA/PMN Number | K112755 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
10/27/2022 |
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 Model Number | ADVIA 560 HEMATOLOGY SYSTEM |
Device Catalogue Number | 11170842 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/04/2022 |
Initial Date FDA Received | 10/27/2022 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |