MAUDE Adverse Event Report: STERIS CANADA CORPORATION 120 CART WASHER

Device Problems Smoking (1585); Device Displays Incorrect Message (2591); Material Deformation (2976); Noise, Audible (3273)

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

Event Date 12/03/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that an employee heard a fire alarm, checked the alarm panel and verified it was coming from the second floor decontamination room.The employee entered the room and observed smoke emitting from the cart washer and the sprinkler system going off.The employee turned off the sprinkler system, heard a whistling sound and observed bowing of the washer on one side.The employee turned off the steam and the noise stopped.The fire department was dispatched however, no evacuations were reported.No injuries were reported but procedures were rescheduled for the following day.

Manufacturer Narrative

A steris service technician inspected the washer and found that the steam valve had stuck in the open position allowing the hot water tank to overheat.The technician repaired the washer, ran a test cycle and confirmed the washer to be operational.No additional issues have been reported.The technician stated that the sprinkler system was located above the washer during the time of the reported event and has since been relocated.The washer is serviced and maintained by the user facility's biomedical department.

• Brand Name: 120 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: 4374631
• MDR Text Key: 5264357
• Report Number: 9680353-2014-00098
• 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: 12/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• 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: 12/03/2014
• 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