MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000A PLATFORM SYSTEM

Model Number EV1000A

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the evaluation findings.Upon completion of the device service history record review, the results will also be submitted.

Event Description

It was reported that a spark was noted that caused a flame with an ev1000a platform system and power adapter cable.It is unknown where the spark originated.The hospital staff was present.The system was unplugged and removed from the patient room.The hospital staff reported a strong electrical odor in the room.It is unknown if there was fluid that came in contact with the ev1000 system or power adapter cable or if the power adapter was mounted in the correct orientation to prevent fluid ingress.A picture of the system showed smoke residue on the system and melted material on the power adapter.There was no patient or hospital staff harm or injury.Attempts are continuing to be made to obtain the product for evaluation.

Manufacturer Narrative

One ev1000a platform system was returned for evaluation.A visual inspection was performed of the pc panel and it was affected slightly by smoke.The databox was found to have a crystalized saline solution residue.This was an indication of dripping of solution.The databox was also affected by smoke around the bracket area.The power supply adapter cable was attached and fused.It was charred at the connection area.The fire and smoke damage indicates that the power supply was mounted with the ac supply in port upside down.There was also a crystalized saline solution on the sides of the power supply brick.The pc panel and the databox were connected to a known good working evec1 cable for functional testing.The system successfully powered on and completed the power on self test, post cycle.The panel was functional and navigating through the various screen functions was successful.The databox was connected to the panel and it was functional, there were no issues noted.It was found that the power cord could not be removed from the power supply brick.The issue was determined to be incorrect positioning of the power supply brick on the stand pole.The orientation was ac side up instead of appropriately, dc side up.This caused ingress of the saline solution into the power supply ac and created a conductive area between the line and ground, thus causing a fire.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported incident was confirmed by evaluation.The root cause of the incident was liquid ingress due to customer mishandling.In the edward¿s operators manual there are warnings that state, ¿the monitor and power adaptors must be positioned in an upright position to ensure ipx1 ingress protection.¿ and ¿shock or fire hazard! do not immerse the ev1000 monitor, databox or cables in any liquid solution.Do not allow any fluids to enter the instrument¿.There is a caution statement that reads ¿do not allow any liquid to come in contact with the power connector.Do not allow any liquid to penetrate connectors or openings in the case.If any liquid does come in contact with any of the above-mentioned items, do not attempt to operate the platform.Disconnect power immediately and call your biomedical department or local edwards representative.¿ there are also photographs in the manual that demonstrate the correct mounting of the power adapter.This is not a design related issue.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective actions will be taken.There were no patient or staff injuries noted in this event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of the monthly review.Please refer to the power supply adapter submission 2015691-2018-01491.

• Brand Name: EV1000A PLATFORM SYSTEM
• Type of Device: EV1000A PLATFORM SYSTEM
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92714
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92714
• Manufacturer Contact: lynn selawski ; one edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7447466
• MDR Text Key: 106073579
• Report Number: 2015691-2018-01490
• Device Sequence Number: 1
• Product Code: DXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100709
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Model Number: EV1000A
• Device Catalogue Number: EV1000A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Treatment: EVPSB100 POWER ADAPTER CABLE
• Patient Age: 57 YR