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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EV1000 ETHERNET CABLE EVEC1 ETHERNET CABLE

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EDWARDS LIFESCIENCES EV1000 ETHERNET CABLE EVEC1 ETHERNET CABLE Back to Search Results
Model Number EVEC1
Device Problems Fire (1245); Fluid/Blood Leak (1250); Melted (1385); Device Emits Odor (1425); Overheating of Device (1437); Sparking (2595)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 11/20/2018
Event Type  malfunction  
Manufacturer Narrative
One evec1 ethernet cable was received for product evaluation. The evaluation found that where the ac power adaptor plugs into the power supply block that it was melted. The evec1 ethernet cable was nearby and there is a melted area on the cable. The root cause is consistent with liquid ingress to the power adaptor which caused a spark and melting of the components. The ifu 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. ¿ the facility has been contacted by letter regarding the ifu warning and the edwards clinical field representative has contacted them regarding the issue. This is not a systemic or design related issue. There is no indication that a manufacturing defect contributed to the failure. The reported event was confirmed by evaluation. The root cause is consistent with liquid ingress and customer mishandling. There will be no further actions taken at this time. 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 a part of the monthly review. The device service history record review was performed and all manufacturing inspections passed with no non-conformances. Refer to the power cords involved, 2015691-2018-05186 and 2015691-2018-05187.
 
Event Description
It was reported that during use, saline dripped onto the power supply cord of the ev1000. As a result, there was a spark and the cord melted. A portion of the evec1 ethernet cable was melted as well. The hospital staff had smelled a burning odor and was alerted to the issue. When they went in the patient¿s room there was a spark that came from the cable and a flame developed for approximately 15 seconds, then it put itself out. The patient was intubated and never breathed in any smoke. The resident disconnected the a-line and cvp and removed the monitor and cables from the room. The patient was being prepared to be removed from the room; however, the fire department arrived and deemed the area safe. A fire extinguisher was brought in and the fire alarm was activated as a precaution. There was no hospital staff or patient harm or injury. Patient demographic information was requested and not provided.
 
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Brand NameEV1000 ETHERNET CABLE
Type of DeviceEVEC1 ETHERNET CABLE
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
one edwards way
irvine, CA 92614
9497564386
MDR Report Key8232968
MDR Text Key132626832
Report Number2015691-2019-00124
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100709
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEVEC1
Device Catalogue NumberEVEC1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
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

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