Brand Name | IU22 DIAGNOSTIC ULTRASOUND SYSTEM |
Type of Device | SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC |
Manufacturer (Section D) |
PHILIPS ULTRASOUND, INC. |
3000 minuteman road |
building 4 |
andover MA 01810 |
|
MDR Report Key | 8114601 |
MDR Text Key | 128732792 |
Report Number | 8114601 |
Device Sequence Number | 1 |
Product Code |
IYN
|
UDI-Device Identifier | 00884838025172 |
UDI-Public | (01)00884838025172 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
11/26/2018 |
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 | 8500-0064-02 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/26/2018 |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/29/2018 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 11/29/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 8395 DA |
|
|