MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-14 for RELIANCE 777 WASHER manufactured by Steris Canada Corporation.
[2921743]
The user facility reported that their reliance 777 was leaking water overnight. It was estimated to have formed a 3x3 foot puddle. No procedural delays/cancellations, no injuries or property damage was reported.
Patient Sequence No: 1, Text Type: D, B5
[10306251]
A steris service technician inspected the unit and found several repairs that needed to be performed - leaking drain valve, air leaks and adjustment to the indexing system. The technician confirmed that the leaking drain valve caused the leak reported by the user. The unit subject of the reported event was manufactured and installed in 1998. The technician performed the necessary repairs, ran test cycles and returned the unit to service. No further issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00102 |
| MDR Report Key | 2831617 |
| Report Source | 06 |
| Date Received | 2012-11-14 |
| Date of Report | 2012-11-14 |
| Date of Event | 2012-10-18 |
| Date Mfgr Received | 2012-10-18 |
| Date Added to Maude | 2013-02-22 |
| 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 LINDSEY MCGOWAN |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927519 |
| 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 777 WASHER |
| Generic Name | WASHER/DISINFECTOR |
| Product Code | LDS |
| Date Received | 2012-11-14 |
| Operator | OTHER HEALTH CARE 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 | 2012-11-14 |