Brand Name | EARLYVUE VS30 VITALS MONITOR |
Type of Device | EARLYVUE VS30 VITALS MONITOR |
Manufacturer (Section D) |
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
hewlett-packard-str. 2, |
b1-3/d6 |
boblingen 71034 |
GM 71034 |
|
Manufacturer (Section G) |
PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH |
hewlett-packard-str. 2, |
b1-3/d6 |
boblingen 71034 |
GM
71034
|
|
Manufacturer Contact |
derek
sammarco
|
222 jacobs st |
cambridge, MA 02141
|
6172455900
|
|
MDR Report Key | 12856564 |
MDR Text Key | 281204331 |
Report Number | 9610816-2021-10504 |
Device Sequence Number | 1 |
Product Code |
DSJ
|
UDI-Device Identifier | 00884838091412 |
UDI-Public | 00884838091412 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190624 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Biomedical Engineer
|
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 | 863380 |
Device Catalogue Number | 863380 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/28/2021 |
Initial Date FDA Received | 11/22/2021 |
Supplement Dates Manufacturer Received | 10/28/2021
|
Supplement Dates FDA Received | 06/14/2022
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/18/2021 |
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 |