MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-25 for RELIANCE SERIES 1227 CART AND UTENSIL WASHER/DISINFECTOR manufactured by Steris Canada Corporation.
[16082255]
The user facility reported a steam leak coming from the door seal of their 1227 reliance cart. A small puddle of water formed approximately 2-3 inches near the unit. No injuries or procedural delays/cancellations reported.
Patient Sequence No: 1, Text Type: D, B5
[16386405]
A steris service technician arrived at the facility, inspected the washer and found a concrete chunk in the washer's condenser which was blocking the drain tubing/connector. The technician resolved this issue by removing the concrete chunk. The technician then ran a test cycle and confirmed the unit to be operating to specification. The steam leak was due to a non-functional condenser caused by an unnoticed concrete chunk that fell into the washer during installation. This unit was installed on june 25, 2014 and is under steris warranty.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2014-00049 |
| MDR Report Key | 3958504 |
| Report Source | 06 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-25 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2014-06-27 |
| Date Added to Maude | 2014-07-25 |
| 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 SERIES 1227 CART AND UTENSIL WASHER/DISINFECTOR |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2014-07-25 |
| 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 | 2014-07-25 |