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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-09-04-25-845
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Microstream Advance Intubated CO2 Filter Line, VitaLine Intubated CO2 Filter Line and FilterLine Intubated CO2 Filter Line
الأجهزة المتأثرة
Products Numbers: 989803204511, 989803204321, 989803204301, 989803204331, 989803204521, 989803204531, 989803204311, 989803204341, 989803159571, 989803159581, 989803160241, 989803160251, 989803160261, 989803182921, 989803182931, 989803105531, 989803105541, 989803105561
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
The potential for difficulty or inability to disconnect an adapter from a patient’s endotracheal tube in order to perform a procedure.
الإجراء التصحيحي
Continue using the products following the instructions in IFU. During setup, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. The airway adapter can be connected to the breathing circuit/tubing in a variety of configurations. These include a direct connection to the endotracheal tube. Philips is issuing an addendum to the IFU, refer to the attachment for more information. Manufacturer action: Instructions and correction.
المرفقات
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