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U.S. Department of Health and Human Services

Class 1 Device Recall EV1000 Clinical Platform

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  Class 1 Device Recall EV1000 Clinical Platform see related information
Date Initiated by Firm March 21, 2019
Date Posted May 21, 2019
Recall Status1 Terminated 3 on November 28, 2023
Recall Number Z-1193-2019
Recall Event ID 82456
510(K)Number K160552  
Product Classification System, measurement, blood-pressure, non-invasive - Product Code DXN
Product EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS

Product Usage:
EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).
Code Information All lots
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Linnette Torres
949-756-4582
Manufacturer Reason
for Recall
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
FDA Determined
Cause 2
Use error
Action On 03/21/19, Urgent Medical Device Safety Notification - Action Required notices were mailed to consignees. The firm strongly advised that consignees be cautious that IV bags and other fluids need to be positioned away from AC power connectors in order to avoid liquid ingress. In addition, consignees were asked to follow installation instructions in the operator's manual and to complete and return the response form. On 03/30/19, Urgent Medical Device Safety Notification - Action Required Addendum was mailed informing customers that if they require assistance they may call Technical Support is 800-822-9837. On 05/10/19, Urgent Medical Device Safety Notification - Action Required Addendum was mailed informing customers that improper mounting of the power supply could result in liquid ingress into the adaptor causing a short. Additional potential causes, are as follows: Reports of Burnt Cables: - We have reports of cables that appear burnt, without smoke, sparks or fire. We continue to investigate to identify all potential causes. One potential cause is the presence of conductive material in the AC inlet of the power supply. - Please assure that there is no conductive material in or near the AC inlet when connecting the AC power cord to the device power supply, and that both the AC power cord and inlet are clean and dry. Reports of Smoke, Sparks or Fire due to Cleaning or Decontamination/Disinfection: - The product instructions indicate that product should be kept dry and the cables should not be immersed in any liquid solution or liquids allowed to penetrate connectors. - Another opportunity for liquid ingress into the power supply could be the cleaning and disinfection process. Although the cleaning instructions in the Operators Manual indicate both to only wipe with a damp cloth and to dry the cable after cleaning, user reports indicate that this process is not always followed. - Please assure that the cleaning instructions as noted in the Oper
Quantity in Commerce 22443
Distribution Worldwide Distribution - US Nationwide : FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR. Foreign (OUS): IT, FI, CO, KR, JP, PL, BE, GR, NL, IL, AT, DK,CA, GB, BR, SA, SE, DE, AU, FR, MX, IN, IC, ZA, ES, TR, NZ, MY, IE, SG, CZ, SI, PT, CH, RE, LK, CR, AR, HK, NO, PY, PA, MT, EG, NP, TN, RU, RO, NA,CL, BH, IR, PH, TH, KZ, DZ, BG, EE, KW, VN, OM, PE, EC, AE, MA, VE, BO, QA, DO, GT, BY, JO, LT, SK, HU, CY, MN, TW, CN
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DXN and Original Applicant = EDWARDS LIFESCIENCES, LLC
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