MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-19 for HYDRASYS manufactured by Sebia Inc.
[49876877]
Patient Sequence No: 1, Text Type: N, H10
[49876878]
Last month we had an electrical safety concern with the sebia hydrasys unit. The instrument was turned on to perform an electrophoresis run. The technologist who was operating the instrument heard a loud popping noise and smelled electrical fire. We unplugged the unit and notified the fire department to make sure there was no fire in the wall electrical outlet. The sebia company was notified. We had the same problem in the fall of last year at the same location, and with the same hydrasys instrument. A similar occurrence also took place two years ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5802677 |
| MDR Report Key | 5802677 |
| Date Received | 2016-07-19 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-05-13 |
| Report Date | 2016-06-10 |
| Date Reported to FDA | 2016-06-10 |
| Date Reported to Mfgr | 2016-06-10 |
| Date Added to Maude | 2016-07-19 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | HYDRASYS |
| Generic Name | APPARATUS, ELECTROPHORESIS |
| Product Code | JJN |
| Date Received | 2016-07-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEBIA INC |
| Manufacturer Address | 400-1705 CORPORATE DRIVE NORCROSS GA 30093 US 30093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-19 |