Brand Name | GE 1.5T 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 Contact |
tammy
lee
|
3000 n grandview blvd, w450 |
waukesha, WI
|
|
MDR Report Key | 10341774 |
MDR Text Key | 208978247 |
Report Number | 2183553-2020-00011 |
Device Sequence Number | 1 |
Product Code |
LNH
|
Combination Product (y/n) | N |
PMA/PMN Number | K052293 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial |
Report Date |
07/29/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/29/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 04/13/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 10/21/2008 |
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 |
Patient Outcome(s) |
Other;
|
Patient Age | 70 YR |
Patient Weight | 70 |
|
|