Brand Name | SURESIGNS VS2+ 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 | 8730169 |
MDR Text Key | 149161529 |
Report Number | 1218950-2019-04566 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00884838028395 |
UDI-Public | (01)00884838028395 |
Combination Product (y/n) | N |
Reporter Country Code | GM |
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 |
06/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/25/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 863278 |
Device Catalogue Number | 863278 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 06/18/2019 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/27/2018 |
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 |
|
|