MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fall (1848); Pain (1994)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived on site to inspect the unit.The technician was unable to recreate the reported leak and did not find any issues with the function or operation of the unit.Per the customer's request, the technician proactively replaced the unit's door gaskets, tested and returned it to service.The reliance 444 washer operator manual states (1-2), "warning - slipping hazard: to prevent slips, keep floors dry.Promptly clean up any spills or drippage." no additional issues have been reported.

Event Description

The user facility reported that an employee slipped and fell on water that had leaked onto the floor from their reliance 444 washer resulting in an employee to experience soreness.

• Brand Name: RELIANCE 444 WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 9885345
• MDR Text Key: 200633689
• Report Number: 9680353-2020-00017
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/26/2020
• 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