Brand Name | SURESIGNS VSI - NBP/SPO2 |
Type of Device | SURESIGNS VSI - NBP/SPO2 |
Manufacturer (Section D) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
andover MA 01810 |
|
Manufacturer (Section G) |
PHILIPS NORTH AMERICA LLC |
3000 minuteman road |
|
andover MA 01810 |
|
Manufacturer Contact |
tara
mackinnon
|
222 jacobs st |
cambridge, MA 02141
|
6172455900
|
|
MDR Report Key | 12453658 |
MDR Text Key | 270827661 |
Report Number | 1218950-2021-10916 |
Device Sequence Number | 1 |
Product Code |
DXN
|
UDI-Device Identifier | 00884838028371 |
UDI-Public | 00884838028371 |
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,User Facility |
Reporter Occupation |
Other
|
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 | 863276 |
Device Catalogue Number | 863276 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Distributor Facility Aware Date | 08/30/2021 |
Initial Date Manufacturer Received |
08/30/2021 |
Initial Date FDA Received | 09/10/2021 |
Supplement Dates Manufacturer Received | 08/30/2021
|
Supplement Dates FDA Received | 11/09/2021
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 02/02/2016 |
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 |
|
|