Brand Name | SOMATOM DEFINITION FLASH AS |
Type of Device | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED |
Manufacturer (Section D) |
SIEMENS HEALTHCARE GMBH |
siemenstrasse 1 |
forchheim, 91301 |
GM 91301 |
|
Manufacturer (Section G) |
SIEMENS HEALTHCARE GMBH |
siemenstrasse 1 |
|
forchheim, 91301 |
GM
91301
|
|
Manufacturer Contact |
rebecca
tudor
|
40 liberty blvd. |
65-1a |
malvern, pa
|
4486484
|
|
MDR Report Key | 10244800 |
MDR Text Key | 197938818 |
Report Number | 3004977335-2020-34701 |
Device Sequence Number | 1 |
Product Code |
JAK
|
UDI-Device Identifier | 04056869003665 |
UDI-Public | 04056869003665 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190578 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
07/07/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/08/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 8098027 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/17/2020 |
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 |
Reuse
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
Patient Age | 2 MO |
Patient Weight | 5 |