MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-21 for CENTRAL MONITORING SYSTEM EDNS-9001 manufactured by Nkus Lab.
| Report Number | 2032233-2020-00101 |
| MDR Report Key | 9742256 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2016-04-04 |
| Date Added to Maude | 2020-02-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHAMA MOOMAN |
| Manufacturer Street | 14 BUNSEN |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2687488 |
| Manufacturer G1 | NKUS LAB |
| Manufacturer Street | 14 BUNSEN ATTN: SHAMA MOOMAN |
| Manufacturer City | IRVINE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRAL MONITORING SYSTEM |
| Generic Name | CENTRAL MONITORING STATION |
| Product Code | DRG |
| Date Received | 2020-02-21 |
| Model Number | EDNS-9001 |
| Catalog Number | EDNS-9001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NKUS LAB |
| Manufacturer Address | 14 BUNSEN ATTN: SHAMA MOOMAN IRVINE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |