Brand Name | DIGITAL RADIOGRAPHY |
Type of Device | GC85A |
Manufacturer (Section D) |
SAMSUNG ELECTRONICS CO., LTD. |
129, samsung-ro, yeongtong-gu |
suwon-si, gyeonggi-do, 443-7 42 |
KS 443-742 |
|
MDR Report Key | 6616173 |
MDR Text Key | 76822563 |
Report Number | 3004938766-2017-00005 |
Device Sequence Number | 1 |
Product Code |
KPR
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
05/26/2017,05/25/2017 |
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 |
Radiologic Technologist
|
Device Model Number | GC85A |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/26/2017 |
Device Age | 3 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 05/26/2017 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 06/06/2017 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|