Brand Name | EPIQ 7 |
Type of Device | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
bothell WA 98021 |
|
Manufacturer (Section G) |
PHILIPS ULTRASOUND, INC |
22100 bothell everett highway |
|
bothell WA 98021 |
|
Manufacturer Contact |
eric
nail
|
22100 bothell everett highway |
bothell, WA 98021
|
|
MDR Report Key | 16240413 |
MDR Text Key | 308117454 |
Report Number | 3019216-2023-00008 |
Device Sequence Number | 1 |
Product Code |
IYN
|
UDI-Device Identifier | 00884838097872 |
UDI-Public | 00884838097872 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132304 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
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 | EPIQ 7 DIAGNOSTIC ULTRASOUND SYSTEM |
Device Catalogue Number | 795201 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/14/2023 |
Initial Date FDA Received | 01/25/2023 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 10/28/2015 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | 3019216-07/16/21-002-C |
Patient Sequence Number | 1 |
|
|