MAUDE Adverse Event Report: PHILIPS VOLCANO CORE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number CORE01

Device Problems Grounding Malfunction (1271); Unintended Electrical Shock (4018)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

Internal reference: (b)(4).Attempts to obtain patient/user information have been unsuccessful.Attempts to obtain the patient information were made via email.Outcome: non-life threatening injury.No treatment was obtained.Additional information received describes the event as a quick shock, nothing audible, no flash.The user pulled hand back immediately, felt mild pain in middle 3 fingers for approximately 2-3 hrs.No treatment was obtained.Lot#, udi and expiration date do not apply to this device.Implant and explant dates: not applicable for this device.Device evaluation: not applicable for this device.A field service engineer visited the customer site, performed electrical safety testing, found that a ground wire running from the core isolation transformer to the bub had been damaged.To resolve the issue the ground wire was crimped to its terminal and the safety electrical safety test performed successfully by the field service engineer.Per the system operators manual, user-performed maintenance includes monthly verification of cable connections.Additionally, the user is to inspect and safety test all isolated connections and system power supply annually.Further, subsection: cable inspection: check placement of pim cable and connector, and ensure cable is protected from accidental damage.Inspect cable connections to ensure secure connections note: as part of the hospital¿s maintenance program, routine safety inspections and testing should be performed annually.Trained hospital technicians should inspect and safety-test all isolated connections.

Event Description

This case was reviewed and investigated according to the manufactures policy.It was reported, when the user was setting up the system for a [patient] case by connecting the bedside controller to the bub (bedside utility box) with the usb cable, they felt [an electric] shock.This adverse event is being submitted because the user experienced an electric shock.

• Brand Name: CORE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): PHILIPS VOLCANO; 2870 kilgore road; rancho cordova CA 95670
• Manufacturer Contact: melissa mangum ; 2870 kilgore road; rancho cordova, CA 95670 ; 8584650468
• MDR Report Key: 11241421
• MDR Text Key: 229092976
• Report Number: 2939520-2021-00005
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K153369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CORE01
• Device Catalogue Number: 300004330631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other