تسجيل الدخول
تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
تواصل معنا
EN
SA-12-08-25-999
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
corpuls3 / corpuls3 Touch
الأجهزة المتأثرة
corpuls3 / corpuls3 Touch
الممثل المعتمد
Al Khateeb United Trading And Contracting Company
سبب المشكلة
The Daily Checks of the Device are not performed consistently or the results of the tests are not being reviewed by users as per the recommended procedure. This deviation from the IFU can result in undetected device readiness issues and may compromise emergency response effectiveness.
الإجراء التصحيحي
To address the issue, the following corrective measures will be implemented: - The IFU will be updated to clearly communicate that execution and verification of the Daily Checks of the Device is mandatory for ensuring the device remainsin a ready-for-use condition. - Users will be instructed that failure to perform and document the daily check constitutes non-compliance with the manufacturer’s operating instructions and may result in delayed or ineffective therapy delivery. In the event of a failed self-test, immediate action must be taken, as described in IFU chapter 11 Procedure in Case of Malfunctions including temporary removal from service, replacement with a backup device, and escalation to your responsible sales and service partner. Manufacturer action: Instructions
المرفقات
عودة للقائمة
