MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-02-15 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[3141417]
The user facility reported that water was leaking from their reliance synergy washer creating a puddle on the floor in the room were the unit is located. The user facility staff contained the water with blankets and continued to use the washer. No injuries or procedural delays/cancellations reported.
Patient Sequence No: 1, Text Type: D, B5
[10460536]
A steris service technician inspected the unit and found that clamps were loose on the hoses near the recirculation pump. The technician tightened the clamps, ran a test cycle and found the unit to be operational.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2013-00015 |
| MDR Report Key | 2963930 |
| Report Source | 06 |
| Date Received | 2013-02-15 |
| Date of Report | 2013-02-15 |
| Date of Event | 2013-01-16 |
| Date Mfgr Received | 2013-01-16 |
| Date Added to Maude | 2013-04-29 |
| 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 | 2013-02-15 |
| 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 | 2013-02-15 |