Brand Name | ACUSON Z6MS ULTRASOUND TRANSDUCER |
Type of Device | ULTRASOUND DEVICE |
Manufacturer (Section D) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
business area ultrasound |
22010 se 51st street |
issaquah WA 98029 |
|
Manufacturer Contact |
khalil
thomas
|
business area ultrasound |
22010 se 51st street |
issaquah, WA 98029
|
4253929180
|
|
MDR Report Key | 6703868 |
MDR Text Key | 286064023 |
Report Number | 3009498591-2017-00110 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K142628 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
10/27/2021 |
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 | Z6MS TRANSDUCER |
Device Catalogue Number | 10436113 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
02/27/2017 |
Initial Date FDA Received | 07/11/2017 |
Supplement Dates Manufacturer Received | 02/27/2017
|
Supplement Dates FDA Received | 07/11/2017
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
|
|