Brand Name | ACUSON |
Type of Device | DIAGNOSTIC ULTRASOUND DEVICE |
Manufacturer (Section D) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
685 east middlefield road |
mountain vew CA 94043 4050 |
|
Manufacturer (Section G) |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
685 east middlefield road |
|
mountain vew CA 94043 4050 |
|
Manufacturer Contact |
karen
smith
|
685 east middlefield road |
mountain view, CA 94043-4050
|
|
MDR Report Key | 5647742 |
MDR Text Key | 45431472 |
Report Number | 3009498591-2016-00131 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Service and Testing Personnel
|
Type of Report
| Initial |
Report Date |
05/11/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/11/2016 |
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 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 05/08/2016 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |