Brand Name | 9900 |
Type of Device | FLUOROSCOPIC X-RAY |
Manufacturer (Section D) |
GE OEC MEDICAL SYSTEMS (SLC) |
384 wright brothers drive |
salt lake city UT 84116 |
|
Manufacturer (Section G) |
GE OEC MEDICAL SYSTEMS (SLC) |
384 wright brothers drive |
|
salt lake city UT 84116 |
|
Manufacturer Contact |
|
384 wright brothers drive |
salt lake city, UT 84116
|
|
MDR Report Key | 5571830 |
MDR Text Key | 42494544 |
Report Number | 1720753-2016-00973 |
Device Sequence Number | 1 |
Product Code |
OWB
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
04/12/2016 |
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 | 9900 |
Device Lot Number | E2-0534 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/24/2016 |
Initial Date FDA Received | 04/12/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 08/14/2008 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|