| Common Device Name | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC |
| Manufacturer (Section D) |
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| 22010 se 51st st |
| issaquah WA 98029 |
|
| Manufacturer (Section G) |
| SIEMENS MEDICAL SOLUTIONS USA, INC. |
| 22010 se 51st st |
|
| issaquah WA 98029 |
|
| Manufacturer Contact |
|
pragya jai
kumar
|
| 22010 se 51st st |
| issaquah, WA 98029
|
|
6506257209
|
|
| MDR Report Key | 25236838 |
| Report Number | 3023245-2026-00038 |
| Device Sequence Number | 5105464 |
| Product Code |
IYN
|
| UDI-Device Identifier | 04056869002750 |
| UDI-Public | 04056869002750 |
| Combination Product (Y/N) | N |
| Initial Reporter State | NY |
| Initial Reporter Country | US |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
User Facility |
| Initial Reporter Occupation |
Other
|
| Type of Report
| Initial,Followup |
| Report Date (Section B) |
05/22/2026 |
| 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
|
| Operator of Device |
Health Professional
|
| Device Model Number | 10441701 |
| Is the Reporter a Health Professional? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 05/18/2026 |
| Supplement Date Received by Manufacturer | Not provided
|
| Initial Report FDA Received Date | 05/20/2026 |
| Supplement Report FDA Received Date | 05/22/2026
|
| Usage of Device |
A
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |
|
|