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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 130 12 13 000
Date submitted: 12/16/2013
Manufacturer:Covidien Ltd
Device Type:Puritan Bennett™ 840 Ventilator
Description:Puritan Bennett™ 840 Ventilator, adult, ventilator
Medical Device Identifier:Please find attached a list of affected software versions
Reason of Field Safety Corrective Action:Puritan Bennett™ 840 ventilator systems with certain software versions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.
Remedy Action:Covidien has developed a software solution to address this issue and it is available now. However, the software update may take an extended period of time to reach all customers. Until the software is updated, users will need to remain vigilant regarding this issue. It is expected that the software update should be installed on all affected systems by the end of 2014.
Athorized Representative/Importer/Distributor:Salehiya Trading Est., (011) 2628939
Report Source:NCMDR
Source Ref. Number:9E1066149E1C6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Covidien.pdf