Brand Name | 9800 |
Type of Device | FLUOROSCOPIC X-RAY |
Manufacturer (Section D) |
GE OEC MEDICAL SYSTEMS (SLC) |
384 wright brothers drive |
salt lake city UT |
|
Manufacturer Contact |
|
384 wright brothers drive |
salt lake city, UT
|
|
MDR Report Key | 6350902 |
MDR Text Key | 68084739 |
Report Number | 1720753-2017-00552 |
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 |
02/22/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/22/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 9800 |
Device Lot Number | 8S-3044 |
Other Device ID Number | NOT APPLICABLE |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/25/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/01/1970 |
Is the Device Single Use? |
No
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Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
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