Brand Name | TRUSYSTEM |
Type of Device | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED |
Manufacturer (Section D) |
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
carl-zeiss strasse 7-9 |
07318 saalfeld, |
GM |
|
Manufacturer Contact |
karen
campbell
|
1046 legrand blvd |
charleston, SC 29492
|
8434161361
|
|
MDR Report Key | 5775416 |
MDR Text Key | 49771503 |
Report Number | 3007143268-2016-00003 |
Device Sequence Number | 1 |
Product Code |
JEA
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
06/10/2016 |
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 | TS7500 |
Device Catalogue Number | 1909796 |
Was Device Available for Evaluation? |
No
|
Event Location |
Hospital
|
Initial Date Manufacturer Received |
06/10/2016 |
Initial Date FDA Received | 07/07/2016 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/01/2016 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|