MAUDE Adverse Event Report: EDWARDS LIFESCIENCES POWER CORD, 110V

Model Number 194371001

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2017

Event Type  malfunction  

Manufacturer Narrative

The device was returned for examination and the evaluation is in progress.Upon return of the evaluation results a supplemental report will be submitted with the evaluation findings.

Event Description

It was reported that there were flames with a clearsight pump unit and the attached power cord.The origin was at the power connection on the back of the pump unit.This occurred during setup of the equipment.The nurse left the room and when he returned there were flames.He disconnected the power source and removed the unit from the patient room.The fire burnt itself out.The patient was present; however, monitoring of the patient had not begun.There was no harm or injury to the patient.There was no harm or injury to hospital personnel.There was no liquid involved that may have sparked the incident.This occurred before patient use; therefore, there are no patient demographics.

Manufacturer Narrative

One power cord, 110v was received for product evaluation.The examination found that there was evidence of a fire at the pump unit and power cord connection area.The end of the power cord was melted and covered in soot.The power cord is scorched in the middle.There is damage to the power cord socket on the pump unit causing the two lugs from the power inlet in the socket to be stuck in the melted power cord.In addition, there is residue that was found around the pump unit that is consistent with liquid ingress.It was determined that the fire originated outside of the pump unit and was localized at the cable/power contact area; this is also consistent with liquid ingress.The root cause of the liquid ingress is customer mishandling.The clearsight ifu in chapter 2 includes a warning that instructs the user, ¿do not allow any liquid to come in contact with the power connector [or] allow any liquid to penetrate connectors or the openings in the case.¿ this is not a systemic or design related issue.There is no indication that a manufacturing defect contributed to this failure.Refer to the clearsight pump unit submission number 2015691-2017-02539.The reported event was confirmed by evaluation.The root cause was determined to be customer mishandling.No further actions will be taken at this time.The device service history record review information will be submitted in a supplemental report when the review has been completed.

Manufacturer Narrative

The device service history record review was not able to be performed.It was discovered that the lot number provided in the initial mdr submission is incorrect.The correct lot number is unknown and not able to be obtained.

• Brand Name: POWER CORD, 110V
• Type of Device: POWER CORD, 110V
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6806191
• MDR Text Key: 83090853
• Report Number: 2015691-2017-02538
• 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,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 194371001
• Device Lot Number: 5810064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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