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الأربعاء - جمادى الآخرة 26, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-09-12-25-1172
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
corpuls3 / corpuls3 Touch Display Module
الأجهزة المتأثرة
Model Corpuls3 - 04302 DT Product Code: CP-4100, CP-04101 Affected software version: REL 4.3.2
الممثل المعتمد
Al Khateeb United Trading And Contracting Company
سبب المشكلة
The Display Module of the corpuls3 system may unexpectedly shut down and initiated an automatic reboot during patient care. This results in a temporary interruption of certain device functions, typically lasting between 15 to 45 seconds, with an average duration of 23 seconds.
الإجراء التصحيحي
The local representative will contact you to arrange for the software update REL 4.4.2 to be installed. In the interim, clinicians should be aware that if a device reboot occurs during critical care (e.g., during cardiac arrest), manual chest compressions should be continued as per standard resuscitation protocol. Patient parameters remain visible on the patient box screen during the reboot process. Manufacturer Actions: Instructions and correction.
المرفقات
عودة للقائمة
