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مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-20-01-25-749
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Medima P100, P200, and P300 Volumetric infusion Pumps
الأجهزة المتأثرة
Medima P100, P200, and P300 Volumetric infusion Pumps manufactured in 2022/2023.
الممثل المعتمد
ALKAMAL IMPORT OFFICE
سبب المشكلة
A potential issue due to an error in the manufacturing process with a specific lot of the stepper motors used to load and release the Free-Flow Protection Clamp (loading and releasing the pump set line). This manufacturing issue can lead to the pump runway not opening to allow the infusion set to be inserted into the pump.
الإجراء التصحيحي
• Customers can continue to use your Medima volumetric pumps following the recommendations below. • If the issue occurs, the pump displays an alarm message indicating that the pump cannot be used. The alarm is an alternating red and black animation with an audible signal. • If this alarm occurs, please contact the manufacturer representative to make arrangements to service the affected pump. The manufacturer has developed a software patch to mitigate this issue. Manufacturer action: instructions and correction.
المرفقات
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