MAUDE Adverse Event Report: VOLCANO CORPORATION S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM; SYSTEM, IMAGING, PULSED ECHO

Model Number 804200001-RF

Device Problems Circuit Failure (1089); Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2014

Event Type  malfunction  

Event Description

It was reported that the volcano s5 system had failed to boot up at the start of the day and the system screen stayed blank.No patient was present at the time of the system failure.The customer had shut down the system by holding the system power button and the system restarted as intended afterwards.A volcano field service engineer (fse) visited the site to investigate the issue and observed burned smell coming from the system.The fse instructed the customer to stop using the system.The fse replaced the system to resolve the customer issue.

Manufacturer Narrative

(b)(4).The imaging system was returned to the manufacturer for evaluation.The imaging system was disassembled and visual inspection discovered a burned capacitor (capacitor #c8) on the internal 32v printer power supply board.The imaging system was turned on by using the volcano logo button located in the center of the control console.The monitor displayed the regular messages regarding system initialization and the system booted to normal patient screen.There were no error messages encountered during initialization of the imaging system; however the damaged printer power supply board rendered the printer unusable.When the printer becomes disabled it would not cause any damage to the imaging system and therefore, the imaging system is still operational.However, the user cannot print a screen image.The printer power supply is a purchased oem component.We could not conclusively determine the actual cause of the burned capacitor; however, this type of failure could occur due to a surge on the output or a random component failure.Volcano will continue to monitor complaints for this failure mode via our standard complaint review process and data review process.No further action is required.

• Brand Name: S5/S5I SERIES INTRAVASCULAR IMAGING SYSTEM
• Type of Device: SYSTEM, IMAGING, PULSED ECHO
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer Contact: kathy turner ; 2870 kilgore rd.; rancho cordova, CA 95670 ; 8002284728
• MDR Report Key: 4190041
• MDR Text Key: 21724002
• Report Number: 2939520-2014-00077
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 804200001-RF
• Device Catalogue Number: 804200001-RF
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2014
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1