Brand Name | GE 3.0T SIGNA HDX MR SYSTEM |
Type of Device | NUCLEAR MAGNETIC RESONANCE IMAGING |
Manufacturer (Section D) |
GE MEDICAL SYSTEMS, LLC |
3200 n grandview blvd. |
waukesha, WI 53188 |
|
Manufacturer (Section G) |
GE MEDICAL SYSTEMS, LLC |
3200 n grandview blvd. |
|
waukesha, WI 53188 |
|
Manufacturer Contact |
andy
koch
|
3200 n. grandview blvd. |
waukesha, WI 53188
|
|
MDR Report Key | 15115649 |
MDR Text Key | 296752726 |
Report Number | 2183553-2022-00010 |
Device Sequence Number | 1 |
Product Code |
LNH
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K052293 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
09/20/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/27/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 09/09/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/25/2011 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 62 YR |
Patient Sex | Female |
Patient Weight | 100 KG |
|
|