Brand Name | VIDIAPORT |
Type of Device | VIDIAPORT HOLDER 3000, MONITOR DUO |
Manufacturer (Section D) |
TRUMPF MEDIZIN SYSTEME GMBH + CO. KG |
carl-zeiss strasse 7-9 |
saalfeld, 07318 |
GM 07318 |
|
Manufacturer Contact |
steffen
ulbrich
|
carl-zeiss strasse 7-9 |
saalfeld, 07318
|
GM
07318
|
6715864140
|
|
MDR Report Key | 6638414 |
MDR Text Key | 77708351 |
Report Number | 9681407-2017-00018 |
Device Sequence Number | 1 |
Product Code |
FSY
|
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K061317 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,user facility |
Reporter Occupation |
Biomedical Engineer
|
Remedial Action |
Repair |
Type of Report
| Initial |
Report Date |
10/07/2016 |
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 | 1714803 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/07/2016
|
Initial Date FDA Received | 06/13/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/11/2013 |
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 |
|
|