SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 054 11 18 000
Date submitted:	11/20/2018

Manufacturer:	GE Healthcare
Device Type:	CARESCAPE B850 MBC303 monitors
Description:	Patient monitor
Medical Device Identifier:	CARESCAPE B850 monitors of version MBC303
Reason of Field Safety Corrective Action:	The following issues may occur when multiple CARESCAPE B850 monitors are connected to the same network and a network overload occurs for a prolonged time due to network misconfiguration: 1. Loss of CARESCAPE B850 monitor connection with Patient Data Module (PDM) or CARESCAPE ONE (CS ONE) module 2. Restart of CARESCAPE B850 monitors using Automatic View On Alarm (AVOA) functionality
Remedy Action:	GE Healthcare will provide revised network installation and user instructions documentation at no cost to you.
Athorized Representative/Importer/Distributor:	GE Healthcare
Report Source:	NCMDR
Source Ref. Number:	ACE5BCB311311
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	GE Healthcare.pdf

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