MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-01 for RELIANCE SYNERGY WASHER manufactured by Steris Canada Corporation.
[3074671]
The user facility reported that water was leaking from their reliance synergy washer. An employee entered the room and slipped and fell in a puddle of water located in the room where the washer is located. The employee went to employee health and was then seen by her physician. Her physician then referred her to an orthopedist.
Patient Sequence No: 1, Text Type: D, B5
[3136338]
The user facility reported that the employee is fine and back to normal work duties.
Patient Sequence No: 1, Text Type: D, B5
[10357412]
A steris service technician inspected the unit and found water "seepage" from the door. He found that the spray arm lock screw had come loose. This caused the spray arm to direct the water towards the door seals. The technician made adjustments to the spray arm and tightened the set screws. He ran test cycles and confirmed the unit was operational. The technician stated that when the spray arm pivoted and water was directed at the door seals that the water would have gone through the water pan under the door and then down the drain. The technician spoke with an employee at the user facility and he stated that he did not see a puddle and was unable to verify the size of the puddle or its location. The user facility is responsible for weekly cleanings of the spray arm. The operator manual states (pp 6-7 to 6-14), "weekly cleaning: hold the fixed portion of the hub and unscrew rotary spray arm ; (3) remove locking pin securing each spray arm on rotary spray arm hub. Remove spray arms. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680353-2012-00092 |
| MDR Report Key | 2815629 |
| Report Source | 06 |
| Date Received | 2012-11-01 |
| Date of Report | 2012-11-01 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-10-08 |
| Date Added to Maude | 2013-02-07 |
| 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 | 2012-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2012-11-01 |