تسجيل الدخول
تسجيل جديد
الجمعة - محرم 2, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-24-06-24-468
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
BiPAP A40 Pro Ventilator, BiPAP A40 EFL Ventilator, and BiPAP A30 EFL Ventilator
الأجهزة المتأثرة
This issue affects all BiPAP A40 Pro Ventilators, BiPAP A40 EFL Ventilators, and BiPAP A30 EFLVentilators.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd.
سبب المشكلة
It has been identified issues in the oxygen accumulation sensor manufacturing process that can cause the sensor to malfunction, inaccurately reporting elevated oxygen levels to the device when elevated levels are not present.
الإجراء التصحيحي
Users to follow the actions provided in the attachment. Action update (2023-CC-SRC-042 Rev D): Actions by Philips Respironics: In the October FSN (2023-CC-SRC-042), Philips Respironics had indicated plans for design changes to the BiPAP A40 Pro, BiPAP A30 EFL, and BiPAP A40 EFL. The BiPAP A30 EFL and BiPAP A40 EFL were part of an EFL limited release. These devices were primarily intended for limited distribution and not manufactured or distributed at scale. Now that these activities have concluded, Philips Respironics is conducting a voluntary market removal of all BiPAP A30 EFL and BiPAP A40 EFL devices. Actions by BiPAP A30 EFL & A40 EFL Device Holders: Contact the Philips Respironics representative specified in this letter for instructions on how to return your BiPAP A30 EFL and BiPAP A40 EFL. Manufacturer action: removal
المرفقات
عودة للقائمة
