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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 143 09 12 000
Date submitted: 9/19/2012
Manufacturer:Heinen & Loewenstein
Device Type:Ventilator, neonatal/paediatric, Leoni plus
Description:Ventilator, neonatal/paediatric
Medical Device Identifier:Serial no.: 0217001xxx, 0217004xxx; Software Version 1.x.x and 2.2.x.;
Reason of Field Safety Corrective Action:During the uninterrupted operation of the LEONI PLUS for more than 49 consecutive days the device may start a highest priority alarm that results in a continuous alarm sound and a visual alarm on the monitor. As a consequence of this the ventilation will be interrupted preventing potential hazards for the patient. This situation is just a potential scenario that may appear in rare cases where the devices are continuously operated and put into the standby mode during periods not being connected to the patient but never shut down completely during a period of 49 days.
Remedy Action:Heinen + Löwenstein GmbH & Co KG prepared Software packages that can be installed on the systems to eliminate the potential alarm situation. In the mean time they kindly ask you to follow the precautions as stated in attached file.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:NCAR
Source Ref. Number:DE-BfArM-2012-09-10-205
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Heinen & Loewenstein.pdf