MAUDE Adverse Event Report: VOLCANO CORPORATION S5IX IMAGING SYSTEM; SYSTEM, S5I, IVUS SYSTEM, PULSED ECHO

Model Number 807400001

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

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

A manufacturer's sales manager reported burning smell emanating from s5i cpu.Afterwards it was not possible to boot up the system.The issue was discovered after the procedure and no patient was involved.The customer had disconnected the cpu and moved it out of the lab.

Manufacturer Narrative

(b)(4): the system was returned to the manufacturer for evaluation.A complete external and internal inspection of the device discovered a significant amount of debris present on the system chassis and on the internal parts.The video card was also discovered to be dusty and the cooling fan on the video card was also jammed.The reported failure was confirmed since investigation revealed burned components on the video card which had caused the reported failure of burning smell.The most likely cause of the video card failure was a jammed cooling fan on the card which caused the video card to overheat and eventually to fail as observed.A video card fan can fail for a variety of reasons.Age and wear are generally the most common reasons the fan bearings get damaged and the fan locks up.Other factors such as high amount of dust buildup as observed on the video card can also be due to a surge on the output or a random component failure.A burned video card as observed, will result in the system boot failure and any further functional testing to verify the secondary reported issue of boot failure was not necessary.We will continue to monitor complaints for this failure mode per our standard trending process.No further action is required.

• Brand Name: S5IX IMAGING SYSTEM
• Type of Device: SYSTEM, S5I, IVUS SYSTEM, PULSED ECHO
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer Contact: kathy turner ; 2870 kilgore rd.; rancho cordova, CA 95670 ; 8587641240
• MDR Report Key: 4309107
• MDR Text Key: 5274535
• Report Number: 2939520-2014-00098
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K123898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 807400001
• Device Catalogue Number: 807400001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/12/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1