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الثلاثاء - ربيع الآخر 22, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-12-08-25-998
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
SOPHIE 2020 ventilator
الأجهزة المتأثرة
Ref. 10386142x, 103861430 --------------------------------------- Updated codes: SOPHIE 2020 ventilator with software PC V4.5.4
الممثل المعتمد
Al Khateeb United Trading And Contracting Company
سبب المشكلة
Sophie 2020 ventilator may fail if the third curve display is activated in the graphic display in non-invasive ventilation mode. ---------------------------------- Updated issue 15 Sep 2025: the software PC V4.5.4 has been withdrawn due to another software error that will lead to the effect, that changes of the alarm limits for FiO2 will no longer be transmitted to the MC. As a result, the effective FiO2 alarm limits remain at the initially configured values, even though the display shows the changed values. Changes of the FiO2 or FiO2 alarm limits will therefore lead to false positive FiO2 alarms.
الإجراء التصحيحي
The device can continue to be used without restriction, but you should refrain from activating the third curve in the graphical display. Fritz Stephan GmbH will provide a new software for the device. ------------------------------------- Updated action 15 Sep 2025: - Please update the software PC V4.5.4 to PC V4.5.5 immediately. The files provided by the download link for QM285 (previous FSCA) have already been updated. (refer to the attachment) - Please also delete all previously downloaded copies of "update.tar"! Manufacturer action: Instructions and correction
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