MAUDE Adverse Event Report: STERIS CORPORATION - DISTRIBUTION CENTER CAVIWAVE PRO ULTRASONIC; ULTRASONIC CONSOLE

Device Problem Fire (1245)

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

Event Date 05/29/2015

Event Type  No Answer Provided  

Event Description

The user facility reported the control panel wires in their caviwave pro ultrasonic unit caught on fire.The user facility was able to extinguish the reported fire.No report of injury.The fire alarm did not sound and no evacuations were required.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the charred wires.The unit has been removed from service and sent to the manufacturer for repairs.The user facility has been provided a loaner unit.Steris service engineering has reviewed the reported event and determined it is likely the wire connections near the control panel loosened over time and caused the reported event.Per section 4: preventive maintenance of the caviwave pro ultrasonic's operator manual, "verify all electrical connections and terminals are tight and secure," at least twice a year.The steris technician discussed maintenance of the unit with the user facility's clinical engineering staff.Steris has conducted in-service training.

• Brand Name: CAVIWAVE PRO ULTRASONIC
• Type of Device: ULTRASONIC CONSOLE
• Manufacturer (Section D): STERIS CORPORATION - DISTRIBUTION CENTER; 6100 heisley rd; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4871362
• MDR Text Key: 6058543
• Report Number: 3003950207-2015-00004
• 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: 06/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Health Care Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2015
• 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
• Patient Outcome(s): Other