Brand Name | JUNO DRF |
Type of Device | TABLE, RADIOLOGIC |
Manufacturer (Section D) |
VILLA SISTEMI MEDICALI S.P.A. |
via delle azalle 3, |
20090 |
buccinasco, |
IT |
|
MDR Report Key | 5080784 |
MDR Text Key | 25946533 |
Report Number | 1217116-2015-00002 |
Device Sequence Number | 1 |
Product Code |
KXJ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Radiologic Technologist
|
Report Date |
08/11/2015,08/06/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
No Information
|
Device Model Number | 709020 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Distributor Facility Aware Date | 08/06/2015 |
Device Age | 1 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/11/2015 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/16/2015 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|