MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-12 for RELIANCE VISION SINGLE CHAMBER WASHER manufactured by Steris Canada Corporation.
[185668946]
A steris service technician arrived onsite to inspect the washer and found the root cause of the reported event is attributed to the drying elements. The drying elements overheated resulting in the reported event. The washer was installed in 2013 and is under steris service agreement for maintenance activities. The last maintenance was performed on december 12, 2019. No issues with the function or operation of the washer were identified at this time. The unit was operating according to specification. The technician performed the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[185668947]
The user facility reported that a burning smell and smoke were coming from their reliance vision single chamber washer. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2020-00010 |
| MDR Report Key | 9825059 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-03-12 |
| 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 | 2020-03-12 |
| 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 | 2020-03-12 |