MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Obstruction of Flow (2423)

Patient Problem Injury (2348)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

No procedure delay or cancellation was reported as a result.The user facility stated the employee subject of the reported event attempted to manually clear a door obstruction after the door obstruction alarm on their reliance 444 washer/disinfector sounded.As the employee tried to clear the door obstruction the door shut on the employee's arm.The door contacted the employee and then raised back up.No medical treatment was sought or administered.The reliance 444 washer/disinfector operator manual states on page 1-1, "warning - personal injury hazard: if an obstruction is present in the wash chamber door and door is unable to raise, do not attempt to remove obstruction from under the door.Door cables may have slackened and door may close at high speed when obstruction is removed.Call a qualified service technician to safely remove obstruction." a steris service technician arrived on-site, inspected the reliance 444 washer/disinfector, and identified the door obstruction system had a delayed response.The technician replaced the basket stopper spring and the door obstruction sensor, tested the unit, and confirmed it to be operating according to specification.The technician notified the user facility of the proper procedure to follow when a door obstruction occurs.No additional issues have been reported with the reliance 444 washer/disinfector.

Event Description

The user facility stated and employee was injured while trying to remove a door obstruction in their reliance 444 washer/disinfector as the door was opening.No medical treatment was sought or administered.

• Brand Name: RELIANCE 444 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 7087807
• MDR Text Key: 95070601
• Report Number: 9680353-2017-00090
• Device Sequence Number: 1
• Product Code: MEC
• 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: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• 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