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

Model Number 807300001

Device Problems Electro-Static Discharge (2149); Device Displays Incorrect Message (2591)

Patient Problem Electric Shock (2554)

Event Date 04/03/2014

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).The manufacturing documentation for this device was reviewed and the device met all quality and manufacturing release criteria.A volcano field service engineer (fse) visited the site following the incident and spoke to the individual that received the shock and was informed that cable connector was loose exposing internal wire connections within the connector when the incident occurred.The fse replaced the ao cable and returned it for evaluation.A successful electrical safety check of the system was conducted by the user's biomedical group.This test was witnessed by the volcano fse.In addition, the volcano fse successfully performed his own applicable electrical safety testing on the system and reported that the system was working as designed and there were no further issues to be reported.The ao cable was returned and evaluated.The complaint was confirmed based on the pictures provided by the user prior to tightening the insulator.This cable is provided with the main system and has been in use since 2011.It is likely that the connector insulation became loose due to movement of the system over time and is an isolated event.

Event Description

After receiving the bad wire error, the user disconnected the wire from the pimmette and verified all the connections to the s5.When the user reconnected the aortic output (ao) cable into the s5 system, they reported feeling a shock.The user noticed the ao cable connector had loosened and bare wires were showing.The user tightened the 1/4" aortic output cable so that no bare wire was exposed and reconnected it to the s5.The user did not require medical attention but brought the incident to the attention of her supervisor.

• Brand Name: VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• Manufacturer (Section G): VOLCANO CORPORATION; 2870 kilgore rd.; rancho cordova CA 95670
• Manufacturer Contact: denise stearns ; 3721 valley centre dr.; san diego, CA 92130 ; 8587204178
• MDR Report Key: 3877139
• MDR Text Key: 148803760
• Report Number: 2939520-2014-00033
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 807300001
• Device Catalogue Number: S5TOW02
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2011
• 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