MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 1227 CART WASHER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 12/28/2016

Event Type  No Answer Provided  

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: RELIANCE 1227 CART WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6277702
• MDR Text Key: 65772019
• Report Number: 9680353-2017-00010
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other