MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER CAVIWAVE SONIC CONSOLE

Device Problem Fire (1245)

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

Event Date 07/28/2014

Event Type  No Answer Provided  

Event Description

A steris service technician was performing service on the caviwave sonic console at the time of the event.The technician initiated a test cycle at which time the unit caught on fire.The power was immediately turned off and disconnected, and the fire extinguished.No injuries or procedural delays/cancellations were reported.

Manufacturer Narrative

The user facility contacted steris service for a quote on the replacement of a "noisy" solenoid valve.The steris field service technician arrived at the facility and reported that while performing a test cycle the supply wires at 1l2 and 1l3 caught on fire.The power to the unit was immediately turned off and disconnected, and the fire extinguished.The caviwave is located in a sterile processing lab classroom and is not utilized for patient care.The unit was installed in (b)(4) 2010 and is not under a steris service contract.The technician's evaluation determined the fire was caused by a loose terminal connection on 1l3.The caviwave maintenance manual table 4.1 states, "service required 4.16 verify all electrical connections and terminals are tight and secure." the maintenance manual instructs that this action is performed a minimum of two times per year.The technician will advise the customer of the required maintenance activities as stated in the maintenance manual.The technician replaced the solenoid valve, terminal block and jumper, performed a test cycle and confirmed the unit was operating to specification.

• Brand Name: CAVIWAVE SONIC CONSOLE
• Type of Device: SONIC CONSOLE
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• 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: 4044364
• MDR Text Key: 4803729
• Report Number: 3003950207-2014-00001
• Device Sequence Number: 1
• Product Code: FLG
• 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: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• 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