Brand Name | TRANSDUCER X8-2T |
Type of Device | TRANSDUCER, ULTRASONIC, DIAGNOSTIC |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC. |
22100 bothell everett hwy |
bothell WA 98021 |
|
MDR Report Key | 9947904 |
MDR Text Key | 187204140 |
Report Number | 9947904 |
Device Sequence Number | 1 |
Product Code |
ITX
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
02/26/2020 |
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 |
Other
|
Device Model Number | 989605455171 |
Device Lot Number | B25YDW |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 02/26/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 04/10/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 04/10/2020 |
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 30295 DA |
|
|