MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-09-12 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[20093855]
The user facility reported a leak from the bottom of the washer, which resulted in a puddle approximately 6 feet from the unit. No injuries, procedural delays or cancellations were reported.
Patient Sequence No: 1, Text Type: D, B5
[20278118]
A steris service technician inspected the equipment, and found a leak in the 2 inch hose. The hose was replaced, and the unit is currently operating within specification. The unit is under steris service contract and was last serviced on (b)(4) 2012, when no leaks were noted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00071 |
| MDR Report Key | 2741395 |
| Report Source | 06 |
| Date Received | 2012-09-12 |
| Date of Report | 2012-09-12 |
| Date of Event | 2012-08-14 |
| Date Mfgr Received | 2012-08-14 |
| Date Added to Maude | 2012-12-27 |
| 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 | 2012-09-12 |
| 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 | 2012-09-12 |