MAUDE Adverse Event Report: VOLCANO CORPORATION S5 IMAGING SYSTEM; SYSTEM, S5, IVUS SYSTEM, PULSED ECHO

Model Number 804200001

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

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4): the affected internal parts of the system were returned to the manufacturer for evaluation and investigated according to volcano policy.A visual inspection of the returned parts discovered a burn spot on the backplane which was consistent with shorting of cooling fan's +12v power supply wires to the ground (chassis).Further inspection confirmed pinched cooling fan wires on the returned power harness.It appears the wiring was inadvertently misrouted and was pinched in between the air dam and the rear cover.This resulted in shorting the 12v power wires with the system chassis and a resulting high amount of current burning the traces in the backplane.We will continue to monitor complaints for this failure mode per our standard trending process.No further action is required.

Event Description

A volcano territory manager (tm) received pictures from a distributor that shows a burn spot on the system motherboard.The distributor also indicates the pc module power harness needs to be replaced.The customer only reported the machine was not able to boot up, but didn't say there was anything unusual.Per additional information from the tm, the failure occured before a patient case and the procedure was finished without ivus.

• Brand Name: S5 IMAGING SYSTEM
• Type of Device: SYSTEM, S5, IVUS SYSTEM, PULSED ECHO
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• Manufacturer Contact: richard welch ; 3721 valley center dr.; ste 500; san diego, CA 92130 ; 8587641301
• MDR Report Key: 4961470
• MDR Text Key: 23383154
• Report Number: 2939520-2015-00045
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K051920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 804200001
• Device Catalogue Number: 804200001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1