MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for RELIANCE 1227 CART WASHER manufactured by Steris Canada Corporation.
[65772019]
A steris service technician arrived onsite to inspect the washer. The technician inspected the washer and observed the drifting condition of the unload washer door as reported by the user facility. The technician stated that the drifting of the door closing was slow which should have allowed time for the employee to remove their arm before the door contacted it. The technician further inspected the washer and found that the hinge pins required adjustment. The technician adjusted the hinge pins and returned the washer to service. The load and unload doors on the 1227 cart washer are manual hinged doors. Since the doors are manual hinged doors, the operator of the device controls the speed of the door closure. The operator manual states (pp. 1-1), "keep hands and fingers away from door or any moving parts to prevent crushing. " a review of 1227 cart washer complaints was completed and revealed the event to be an isolated occurrence.
Patient Sequence No: 1, Text Type: N, H10
[65772020]
The user facility reported that the unload door on their 1227 cart washer drifted and closed on an employee's arm. The employee sought and received medical treatment at the facility's emergency department. The user facility stated that the employee is back to work.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680353-2017-00010 |
| MDR Report Key | 6277702 |
| Date Received | 2017-01-25 |
| Date of Report | 2017-01-25 |
| Date of Event | 2016-12-28 |
| Date Mfgr Received | 2016-12-28 |
| Date Added to Maude | 2017-01-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATHRYN CADORETTE |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927231 |
| Manufacturer G1 | STERIS CANADA CORPORATION |
| Manufacturer Street | 490, ARMAND-PARIS |
| Manufacturer City | QUEBEC, QUEBEC GIC 8A3 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | GIC 8A3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RELIANCE 1227 CART WASHER |
| Generic Name | WASHER |
| Product Code | FLH |
| Date Received | 2017-01-25 |
| 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 GIC 8A3 CA GIC 8A3 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-25 |