Brand Name | CENTRAL MONITORING SYSTEM |
Type of Device | CENTRAL MONITORING STATION |
Manufacturer (Section D) |
NKUS LAB |
5 jenner, suite 180 |
attn: shama mooman |
irvine CA 92618 |
|
Manufacturer (Section G) |
NKUS LAB |
5 jenner, suite 180 |
attn: shama mooman |
irvine CA 92618 |
|
Manufacturer Contact |
shama
mooman
|
5 jenner, suite 180 |
irvine, CA 92618
|
9492687708
|
|
MDR Report Key | 8254834 |
MDR Text Key | 133863961 |
Report Number | 2032233-2019-00027 |
Device Sequence Number | 1 |
Product Code |
DRG
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K102106 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial,Followup |
Report Date |
11/06/2019 |
1 Device was Involved in the Event |
|
0 Patients were Involved in the Event: |
|
Date FDA Received | 01/16/2019 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | EDNS-9001 |
Device Catalogue Number | EDNS-9001 |
Device Lot Number | NOT APPLICABLE |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/06/2019 |
Distributor Facility Aware Date | 10/29/2019 |
Device Age | 62 MO |
Event Location |
Hospital
|
Date Report to Manufacturer | 11/06/2019 |
Date Manufacturer Received | 10/29/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/08/2013 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | NOT APPLICABLE |