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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-23-11-24-683
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Sophie und Sophie 2020 neonatal ventilator
الأجهزة المتأثرة
Ref. 1038614xx All device models of Sophie und Sophie 2020
الممثل المعتمد
Al Khateeb United Trading And Contracting Company
سبب المشكلة
A possible of mean airway pressure loss occurred under the combined ventilation mode HFO+IMV.
الإجراء التصحيحي
You can continue to use the Sophie device, but you should avoid HFO-IMV mode if possible. If you absolutely want to use HFO-IMV mode, you should check the measured value display for peep and mean pressure immediately after each technical alarm. If a lowered peep and/or mean pressure has occurred, you can stabilize the pressure by temporarily switching from HFO-IMV to HFO-CPAP and back. To avoid an undesired drop in ventilation pressure under HFO-IMV, you should never disconnect the device from gas supply during operation of the device and avoid any loss of pressure in the breathing circuit, e.g. due to disconnection. A software solution will be developed by Fritz Stephan GmbH to prevent a drop in PEEP and MAP under HFOIMV and introduce additional pressure monitoring. The local agent of Fritz Stephan GmbH will contact you as soon as the software solution is available to arrange an appointment of the update. Manufacturer Action: Instructions and Correction.
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