تسجيل الدخول
تسجيل جديد
الجمعة - محرم 2, 1447
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-21-03-24-338
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
OmniLab Advanced + (OLA+)
الأجهزة المتأثرة
All OmniLab Advanced + (OLA+) devices
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd.
سبب المشكلة
Potential of interruptions and/or loss of therapy due to a Ventilator Inoperative Alarm condition.
الإجراء التصحيحي
Philips Respironics is issuing the updated attachement of FSCA letter to inform all customers that the risk to patient safety is not increased due to the Ventilator Inoperative Alarm condition, and therefore the use of the OmniLab Advanced + (OLA+) devices can continue. Review of the OLA+ User Manual is essential to understanding the intended use and performance of the device. In the event of a Ventilator Inoperative Alarm condition, follow the steps in Appendix A of the attachement: Instructions on Performing the Hard Reboot to restore device function. Manufacturer action: Instructions and correction.
المرفقات
عودة للقائمة