MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-16 for CER 1 OPTIMA manufactured by Medivators Inc..
| Report Number | 2150060-2020-00009 |
| MDR Report Key | 9836058 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2006-03-03 |
| Date Added to Maude | 2020-03-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 9800 59TH AVE N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Manufacturer G1 | MEDIVATORS INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CER 1 OPTIMA |
| Generic Name | AUTOMATED ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2020-03-16 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-16 |