MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-20 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[16872995]
The user facility reported the unit was leaking water. The resulting puddle was larger than 3 x 3 feet. No procedural delays or cancellations have been reported. No property damage was reported.
Patient Sequence No: 1, Text Type: D, B5
[17088451]
A steris service technician inspected the unit, and found a broken drying valve body. The water reduction box nut had loosened, and fell into the recirculation pump. This created vibrations and resulting in the body drying valve to crack. The unit was repaired, tested, found to be operational and returned to service.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00103 |
| MDR Report Key | 2840696 |
| Report Source | 06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-11-20 |
| Date of Event | 2012-10-23 |
| Date Mfgr Received | 2012-10-23 |
| Date Added to Maude | 2013-02-26 |
| 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 SYNERGY WASHER |
| Generic Name | WASHER |
| Product Code | LDS |
| Date Received | 2012-11-20 |
| 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 | 2012-11-20 |