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

Model Number 804200001

Device Problems Charred (1086); Failure to Power Up (1476); Electrical Shorting (2926)

Patient Problems No Patient Involvement (2645); Not Applicable (3189)

Event Date 03/11/2015

Event Type  malfunction  

Event Description

A volcano field service engineer (fse) reported when booting up the s5 system after a preventive maintenance (pm), it started to release heavy smoke into the air.It did not occur during an active procedure; therefore, no pt was involved.The system was taken outside the catheterization lab for the preventive maintenance (pm) and it is when the engineer wanted to reboot the system that the heavy smoke came out.

Manufacturer Narrative

(b)(4).The system was returned to the mfr for eval.A visual outside inspection of the returned system and monitor was performed and no damage was noticed.The system cooling fan area smelled of burned electronics.The system was disassembled to inspect the internal parts.Visual internal inspection discovered a burned back plane on the system which was consistent with shorting of cooling fans +12v power supply wires to the ground (chassis).Further inspection discovered pinched cooling fan wires inside the system.During the preventive maintenance when closing the rear cover the fse inadvertently pinched the fan wires between the air dam and the rear cover.This resulted in shorting the +12v power wires with the system chassis and resulting high amount of current and heat burned the traces in the backplane and generated the reported smoke.This rendered the system non-functional afterwards.We will continue to monitor complaints for this failure mode per our standard trending process.No further action is required.

• Brand Name: S5 IMAGING SYSTEM
• Type of Device: SYSTEM, S5, IVUS SYSTEM, PULSED ECHO
• Manufacturer (Section D): VOLCANO CORPORATION; rancho cordova CA
• Manufacturer Contact: richard welch ; 2870 kilgore rd.; rancho cordova, CA 95670 ; 8587641301
• MDR Report Key: 4692159
• MDR Text Key: 5647795
• Report Number: 2939520-2015-00026
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• 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: 04/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1