SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 102 03 18 000
Date submitted:	3/20/2018

Manufacturer:	Draeger Medical Systems
Device Type:	The Infinity® Acute Care System and Standalone Infinity M540 patient monitor.
Description:	Patient monitor
Medical Device Identifier:	• The Infinity® Acute Care SystemTM (IACS); released software versions VG2.2 to VG4.1 • Standalone Infinity® M540 patient monitor; released software versions VG2.2 to VG4.1
Reason of Field Safety Corrective Action:	When the M540 patient monitor is used with the Infinity Mcable Mainstream CO2 (M11.1), revision 16 sensor, the M540 patient monitor will reboot if the sensor enters a reduced accuracy mode. The M540 patient monitor may enter a fail-state if repeated reboots occur.
Remedy Action:	Distribute a Safety Notice to customers that have systems with VG2.2 to VG4.1 software to provide instructions with regards to incompatibility of the listed software with the Mainstream CO2, revision 16 sensor.
Athorized Representative/Importer/Distributor:	Draeger Arabia Co. Ltd.
Report Source:	NCMDR
Source Ref. Number:	D999B1F8F140C
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Draeger Medical.pdf

View History