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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 072 01 16 000
Date submitted: 1/19/2016
Manufacturer:Philips Healthcare
Device Type:Trilogy 100, Trilogy 200, Garbin, Garbin Plus, Trilogy O2, Trilogy 202, Trilogy EC
Description:ventilator
Medical Device Identifier:Software versions released since January 29, 2015: 13.2.04, 13.2.05, 14.0.00, and 14.1.01
Reason of Field Safety Corrective Action:The listed Trilogy devices support dual therapy prescriptions, and two prescriptions may be programmed by a healthcare professional specific to the patient’s needs as prescribed by physician. Philips Respironics has become aware that Trilogy Ventilators with software versions 13.2.04, 13.2.05, 14.0.00 or 14.1.01 are susceptible to an inadvertent change between prescriptions. This may occur under a particular set of operating conditions and after a specific sequence of key presses without requiring confirmation of the change by the user.
Remedy Action:-Affected devices can continue to be used in accordance with device Instructions for Use and this Field Safety Notice
-Philips will soon release updated device software to prevent the issue described above. The updated device software will be available on my.respironics.com.
Athorized Representative/Importer/Distributor:Philips Healthcare Saudi Arabia Ltd.
Report Source:NCMDR
Source Ref. Number:8B506FCEBD2D5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Philips Healthcare.pdf