Brand Name | SENTEC V-SIGN |
Type of Device | OXIMETER, EAR |
Manufacturer (Section D) |
IMAGENIX, INC |
s65 w35739 piper rd. |
eagle WI 53119 |
|
MDR Report Key | 7468483 |
MDR Text Key | 106741662 |
Report Number | 7468483 |
Device Sequence Number | 1 |
Product Code |
DPZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
03/23/2018,04/17/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/27/2018 |
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | SDMS |
Other Device ID Number | VS-A/P/N |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/23/2018 |
Device Age | 6 YR |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/23/2018 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|