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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-20-02-25-792
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Microstream™ Advance Neonatal-Infant and Adult-Pediatric Intubated CO2 Filter Line, Microstream™ Luer Adult-Pediatric Intubated CO2 Filter Line and Microstream™ Luer Adult-Pediatric Airway Adapter Sampling Line devices
الأجهزة المتأثرة
Please refer to the attachment for details of the affected devices.
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
The potential of inability to, or difficulty in disconnecting the adapter from the endotracheal tube.
الإجراء التصحيحي
Continue to use the above devices following the instructions provided in the IFU. As noted in the IFU, during setup, ensure that the airway adapter can be easily attached and detached from the breathing circuit/tubing before proceeding. The airway adapter can be connected to the breathing circuit/tubing in a variety of configurations. These include a direct connection to the endotracheal tube. In September 2025, Medtronic is issuing an update to the Instructions for Use (IFU) for these devices, refer to the attachment for more information. Manufacturer action: Instructions and correction.
المرفقات
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