MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-29 for EPS RELIANCE manufactured by Steris Corp.
[20119120]
Multiple failures of eps reliance over 6 month period. Abort of pre-system checkout prior to use or while in use. System has failed while washing scopes and during pre-use check out causing delay to pt procedures and workflow.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5042957 |
| MDR Report Key | 4825082 |
| Date Received | 2015-05-29 |
| Date of Report | 2015-05-29 |
| Date of Event | 2015-05-29 |
| Date Added to Maude | 2015-06-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPS RELIANCE |
| Generic Name | EPS RELIANCE |
| Product Code | NZA |
| Date Received | 2015-05-29 |
| Model Number | EPS RELIANCE |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORP |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-29 |