MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-16 for RELIANCE ENDOSCOPE PROCESSOR manufactured by Steris Canada Corporation.
[5377083]
The user facility reported a hose connection on their reliance eps detached at the connection point to the facility's incoming hot water supply. Hot water covered the floor, releasing steam and subsequently activating the fire alarm. No injuries or procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[12756162]
A steris field service technician arrived onsite, inspected the unit, and confirmed the hose connection had detached, resulting in the reported leak. Upon further investigation, the technician identified the user facility's hot water supply outlet was not within the approved range specified by steris install requirements for temperature and pressure. The technician identified the incoming water pressure was higher than the reliance eps specifications and may have contributed to the hose connection failure. The technician made the necessary repairs to the reliance eps hose connections, tested the unit and confirmed the unit was operating to specification. The device history record for the reliance eps was reviewed and confirmed the unit was manufactured according to device specification. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2015-00008 |
| MDR Report Key | 4427594 |
| Report Source | 06 |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-16 |
| Date of Event | 2014-12-18 |
| Date Mfgr Received | 2014-12-19 |
| Date Added to Maude | 2015-02-06 |
| 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 | 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 ENDOSCOPE PROCESSOR |
| Generic Name | PROCESSING SYSTEM |
| Product Code | NZA |
| Date Received | 2015-01-16 |
| 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 | 2015-01-16 |