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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-21-03-24-339
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
All BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro devices
الأجهزة المتأثرة
All BiPAP A30, BiPAP A30 EFL, BiPAP A30 Hybrid, BiPAP A40, BiPAP A40 EFL, BiPAP A40 Pro Devices, all of which are designed with a Ventilator Inoperative condition, are in scope of this FSN.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd.
سبب المشكلة
Interruptions and/or loss of therapy due to a Ventilator Inoperative alarm, which occurs when the ventilator detects an internal error or a condition that may affect therapy. Philips Respironics is clarifying the labeled intended use of the BiPAP A40 and BiPAP A40 Pro by removing “Respiratory Failure.” This clarification is intended to prevent potential misinterpretation as the product is not designed or intended for life support applications. Philipa is providing an update for the patient population who cannot tolerate interruptions or loss of therapy. For patients who cannot tolerate interruption or loss of therapy, including patients who use a BiPAP A40 Pro device for more than 8 hours a day and/or who are invasively ventilated, an alternative ventilator is required. This determination should be made under the guidance of a physician.
الإجراء التصحيحي
Based on patient conditions, Philips Respironics will offer the following options to users: - For users who can tolerate therapy interruptions, the device can continue to be used or an alternate device will be made available at the user’s discretion. - For users who cannot tolerate interruptions or loss of therapy, alternate therapy is required, and financial compensation for customers will be made available. Please refer to the attachment for updated actions details that should be taken by the customer / user.
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