Brand Name | SURESIGNS VSI - NBP/SPO2 |
Type of Device | PATIENT MONITOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
MDR Report Key | 6266715 |
MDR Text Key | 65679501 |
Report Number | 1051786-2017-00002 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
PMA/PMN Number | K112652 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Type of Report
| Initial,Followup,Followup |
Report Date |
01/10/2017 |
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 | 863276 |
Was Device Available for Evaluation? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
01/10/2017 |
Initial Date FDA Received | 01/20/2017 |
Supplement Dates Manufacturer Received | Not provided 01/10/2017
|
Supplement Dates FDA Received | 04/12/2017 09/28/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|