MAUDE Adverse Event Report: STERIS CANADA CORPORATION 120 CART WASHER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/06/2014

Event Type  No Answer Provided  

Event Description

The user facility expressed dissatisfaction with their 120 cart washer.

Manufacturer Narrative

Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

A steris service technician inspected the washer and found the incorrect model of illumination bulb installed and not functioning.In addition, he found a blown control fuse.The technician removed and replaced the bulb and blown fuse.The technician further inspected the washer and found several components were not functioning properly, specifically the motor fan, tank heater coil and water booster tank.The washer is approximately 17 years old and is serviced and maintained by the user facility.Steris recommended to the user facility that the washer be replaced or be taken out of service due to the technician's findings and age of the unit.The user facility continues to use the washer until a decision on steris' recommended actions are made.

Event Description

The user facility further reported that a ready light is not illuminating.No injuries or procedural delays/cancellations were reported.

• 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: 3900571
• MDR Text Key: 20298142
• Report Number: 9680353-2014-00045
• 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,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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: 06/06/2014
• 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