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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 066 10 11 000
Date submitted: 10/23/2011
Manufacturer:Draeger Medical Inc
Device Type:Ventricular Fibrillation ,Patient Monitor
Description:Ventricular Fibrillation, Spo2 measurements
Medical Device Identifier:Delta , Delta XL , Vista XL , Gamma XXL and kappa product MS18597,MS18596,MS18853,MS18986,MS18852 software versions are VF6.2,VF6.3 ,VF6.4,VF7.1 and VF7.2
Reason of Field Safety Corrective Action:Ventricular Fibrillation (Vfib) arrhythmias will not be recognized by the monitor and will not alarm when the masimo SET pod is used for Spo2 measurements , there have been no patient injuries reported. Our investigation determined that this condition is due to a software anomaly will result in the Vfib alarm not sounding for any Vfib arrhythmia condition that arises
Remedy Action:Draeger Service representative will contact customers to schedule time to inspect and upgrade the software in affected monitors, the software upgrade will be provided free of charge. Users should be aware of the potential for the above behavior
Athorized Representative/Importer/Distributor:International Medical Development Co. Ltd. Riyadh (01)4623000
Report Source:NCMDR
Source Ref. Number:BB8AB90ABB2C3
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments