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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 117 06 18 000
Date submitted: 6/28/2018
Manufacturer:GE Healthcare
Device Type:CARESCAPE R860, ENGSTROM CARESTATION and ENGSTROM PRO
Description:Ventilator
Medical Device Identifier:Neonatal Flow Sensor Cable (1505-5604-000 Lot # 1804) used on CARESCAPE R860 1506-8600-000, ENGSTROM Carestation 1505-9000-000, Engstrom Pro 1505-9003-000. Contained in Neonatal Software Upgrade Kit 2080496-010.
Reason of Field Safety Corrective Action:The Neonatal Flow Sensor Cable may be missing the connector housing exposing the wires in the cable. If the exposed wires break, primary ventilation parameters could be lost (Flow and Tidal Volume). This issue may cause indirect but reversible changes in the patient’s condition as these parameters, among other information, are used in choosing appropriate ventilator settings for the patient
Remedy Action:GE Healthcare will replace all affected products at no cost to you. Complete and return the attached “Customer Response” form via e-mail to Recall34092.NFSCable@ge.com and GE Healthcare will provide replacement cables at no cost to you.
Athorized Representative/Importer/Distributor:GE Healthcare
Report Source:NCMDR
Source Ref. Number:BC7F1B6BD3294
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: GE Healthcare.pdf