Brand Name | SURESIGNS VS2+ NBP/SPO2 |
Type of Device | SURESIGNS VS2+ NBP/SPO2 |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
andover MA 01810 |
|
MDR Report Key | 11376220 |
MDR Text Key | 241399011 |
Report Number | 1218950-2021-10021 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00884838028395 |
UDI-Public | 00884838028395 |
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 |
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 | 863278 |
Device Catalogue Number | 863278 |
Was Device Available for Evaluation? |
No
|
Distributor Facility Aware Date | 02/11/2021 |
Initial Date Manufacturer Received |
02/11/2021 |
Initial Date FDA Received | 02/24/2021 |
Supplement Dates Manufacturer Received | 02/11/2021
|
Supplement Dates FDA Received | 03/15/2021
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
|
|