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الجمعة - شعبان 11, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-21-01-26-1231
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Intra-Aortic Balloon Pump
الأجهزة المتأثرة
Product Description: CS100 IABP CS300 IABP Please refer to the attachment for more details of the affected products.
الممثل المعتمد
ALJEEL MEDICAL COMPANY
سبب المشكلة
It has been identified by Datascope the battery runtime and cycle specifications contained in the affected devices’ Instructions for Use (IFU) need to be updated.
الإجراء التصحيحي
• Please forward the attachment to all current and potential CS300 and/or CS100 Intra-Aortic Balloon Pump users within your facility. • Confirm Users are aware of IFU clarifications for batteries. There is no indication that battery cycles need to be monitored. Replace CS100/CS300 batteries (Part #: 0146-00-0039) every three years, and when a battery fails the Battery Runtime Test. No additional Preventative Maintenance or testing is required. Manufacturer's action: Instructions.
المرفقات
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