MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-21 for STERIS AMSCO SONIC BATH SCI224C manufactured by Steris.
[63130006]
At approx 1410, an endo tech noted that the sonic washer in surgical services dept had some flames coming from it. No equipment was in the washer at the time and it was not running. It was plugged in. Fire was put out using the nearest fire extinguisher. Fire chief presented to facility; noted fire panel operating properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066869 |
| MDR Report Key | 6199785 |
| Date Received | 2016-12-21 |
| Date of Report | 2016-12-21 |
| Date of Event | 2016-12-08 |
| Date Added to Maude | 2016-12-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | STERIS AMSCO SONIC BATH |
| Generic Name | SONIC WASHER |
| Product Code | FLG |
| Date Received | 2016-12-21 |
| Model Number | SCI224C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS |
| Manufacturer Address | 5960 WEISLEY RD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-21 |