MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for MEDIVATOR DSD EDGE manufactured by Medivators Inc..
[112154161]
Medivator dsd edge caught on fire during reprocessing of endoscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078010 |
| MDR Report Key | 7633335 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-30 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIVATOR DSD EDGE |
| Generic Name | AUTOMATIC ENDOSCOPE REPROCESSOR |
| Product Code | NVE |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-06-06 |
| Model Number | MEDIVATOR DSD EDGE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS INC. |
| Manufacturer Address | PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-06-22 |