MAUDE Adverse Event Report: STERIS CANADA CORPORATION 1227 CART WASHER

Device Problems Fumes or Vapors (2529); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that a cycle aborted with a message of "alarm #44-unload door open during cycle".The employee opened the unload door and vapor released subsequently setting off the sprinkler system.No fire alarms were triggered and the fire department was not dispatched.No evacuations were reported.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

A steris service technician arrived onsite and found the unload door to be open and the cart washer to be turned off via the emergency stop switch on the unload side of the washer.The technician ran several cycles and could not duplicate the reported event.The technician replaced the unload door switch, ran test cycles and confirmed the washer to be operational.No additional issues have been reported.

• Brand Name: 1227 CART WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4152736
• MDR Text Key: 4787618
• Report Number: 9680353-2014-00083
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• 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?: Yes
• Date Manufacturer Received: 09/09/2014
• 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