MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER/DISINFECTOR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The investigation of this event is currently in process.A follow-up mdr will be submitted once additional information becomes available.

Event Description

The user facility reported the transfer cart for their reliance synergy washer/disinfector was not operating properly.The user facility temporarily removed the transfer cart from service.No report of injury or procedural delay or cancellation.

Manufacturer Narrative

The technician replaced the wheels, tested the locking mechanisms, and confirmed the transfer cart was operating according to specification.Section 3.2 of the transfer cart's operator manual states, "inspect wheels to ensure they roll smoothly.Align if they are misaligned, replace if worn or if brakes are broken." the customer will be made aware of proper maintenance and the routine inspection requirements associated with their unit.No additional issues have been reported.

Event Description

The user facility reported the transfer cart for their reliance synergy washer/disinfector was not operating properly.No report of injury or procedural delay or cancellation.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR
• 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: 5004753
• MDR Text Key: 24789688
• Report Number: 9680353-2015-00049
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 08/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• 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