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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-23-12-24-715
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Oxylog 3000 plus
الأجهزة المتأثرة
All Oxylog 3000 plus devices Part No 5704811 and 5704813
الممثل المعتمد
Draeger Arabia Co Ltd
سبب المشكلة
The Oxylog 3000 plus emergency and transport ventilators have stopped ventilation due to discharged battery if the alarm “No int. battery charging” was not handled according to the Instructions for Use (IFU) and a transport with the device was started.
الإجراء التصحيحي
It has been decided by Dräger to update the Instructions for Use with the check described in the attachment of May 2023. This check, which must be performed prior to each transport, will avoid that a transport is started with an active alarm “No int. battery charging”. A stop of ventilation due to a depleted battery because Oxylog 3000 plus does not switch to mains supply after battery operation would therefore not occur. Manufacturer Action: Instructions and Correction.
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