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الأربعاء - ربيع الأول 25, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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أسئلة شائعة
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EN
SA-16-09-25-1057
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
CARDIOSAVE Hybrid and CARDIOSAVE Rescue Intra-Aortic Balloon Pumps (IABPs)
الأجهزة المتأثرة
Please refer to the attachment.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
Unexpected shutdown of the Cardiosave IABP while providing therapy in very rare instances.
الإجراء التصحيحي
Please ensure that all Cardiosave IABP users and nurse Educators are able to access and receive the updated Cardiosave IABP education and training materials available at the g link: https://fs7.formsite.com/MedicalAffairs/s94juj9zlb/index. A Datascope/Getinge SSU representative will schedule a service visit to impacted customers to install the updated software (D.03), and hardware update to PIM and test the Cardiosave IABP to ensure it functions as intended prior to releasing it for clinical use. The D.03 Operating Instructions for Hybrid and Rescue IABP configurations will be provided to the customer by Datascope/Getinge SSU representative, refer to the attchment for more information. Manufacturer's Action: Instructions and Correction.
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