Brand Name | SURESIGNS VSI - NBP/SPO2 |
Type of Device | PATIENT MONITOR |
Manufacturer (Section D) |
PHILIPS MEDICAL SYSTEMS |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer Contact |
robert
corning
|
3000 minuteman road |
andover, MA 01810
|
9786871501
|
|
MDR Report Key | 8253103 |
MDR Text Key | 133240598 |
Report Number | 1218950-2019-00499 |
Device Sequence Number | 1 |
Product Code |
DXN
|
Combination Product (y/n) | N |
Reporter Country Code | IT |
PMA/PMN Number | K112652 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,u |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
12/20/2018 |
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
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
12/20/2018 |
Initial Date FDA Received | 01/16/2019 |
Supplement Dates Manufacturer Received | 12/20/2018
|
Supplement Dates FDA Received | 01/31/2019
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/25/2013 |
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 |
|
|