MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-06 for RELIANCE VISION SINGLE CHAMBER WASHER manufactured by Steris Canada Corporation.
[185192080]
Contrary to the reported event, user facility personnel informed the steris service technician that arrived onsite that there was no fire and only smoke. The technician performed an inspection of the reliance vision single chamber washer and found the unit to not be operational. A replacement unit will be installed. The unit subject of this event will be returned to steris for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[185192081]
The user facility reported smoke was coming from their reliance vision single chamber washer and caught fire. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2020-00008 |
| MDR Report Key | 9800559 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-07 |
| Date Mfgr Received | 2020-02-07 |
| Date Added to Maude | 2020-03-06 |
| 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 | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR, OH |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANCE VISION SINGLE CHAMBER WASHER |
| Generic Name | WASHER |
| Product Code | MEC |
| Date Received | 2020-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA CORPORATION |
| Manufacturer Address | 490 ARMAND-PARIS QUEBEC, GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |