Brand Name | HITACHI |
Type of Device | SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC |
Manufacturer (Section D) |
HITACHI, LTD. |
1959 summit commerce park |
twinsburg OH 44087 |
|
MDR Report Key | 10407147 |
MDR Text Key | 202930976 |
Report Number | 10407147 |
Device Sequence Number | 1 |
Product Code |
IYO
|
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 |
06/12/2020 |
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 |
Health Professional
|
Device Model Number | C41V |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 06/12/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/14/2020 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/14/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 25550 DA |
|
|