MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-01-31 for RELIANCE 220 CART WASHER manufactured by Steris Canada Corporation.
[15204492]
The user facility reported the washer was leaking water. The water spread into the operator's working area. No injuries or procedural delays/cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[15543533]
A steris service technician arrived at the facility, inspected the washer and found the gasket holder was not properly attached to the door causing the water leak. The technician reattached the door seals, completed a test cycle and confirmed the unit was operating to specification. The gasket holder damage was caused by improper loading of the cart into the washer. While onsite, the technician instructed the facility on the proper way of loading carts into the washer. The unit was installed in 1999 and has not been under a steris service contract since 2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2014-00014 |
| MDR Report Key | 3601638 |
| Report Source | 06 |
| Date Received | 2014-01-31 |
| Date of Report | 2014-01-31 |
| Date of Event | 2014-01-10 |
| Date Mfgr Received | 2014-01-10 |
| Date Added to Maude | 2014-03-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC8A3 |
| 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 220 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2014-01-31 |
| 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, QUEBEC GIC8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-31 |