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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-17-04-25-862
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ParaPAC plus™ Model 300 and Model 310 Ventilator
الأجهزة المتأثرة
ParaPAC plusTM plus kit without internal PEEP & CPAP List Number: P300NXX ParaPAC plusTM kit with internal PEEP & CPAP List Number: P310NXX
الممثل المعتمد
AL MADAR MEDICAL SERVICES COMPANY
سبب المشكلة
When a paraPAC plus™ventilator is switched to the operating mode of ‘Ventilate’, paraPAC plus™ ventilators may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.
الإجراء التصحيحي
There is no need to return or discontinue using your paraPAC plusTM, at this time. When using the device, all instructions, including warnings and cautions in the User Manual must be followed with heightened awareness. This is inclusive, but not limited to the following: • Constant monitoring of the patient • Blood oxygenation and expired carbon dioxide levels should be monitored independently using pulse oximetry and capnography. • All pre-use checks must be performed before each use. • Alternative means of ventilation such as bag mask ventilation, must be available in the event of ventilator failure or malfunction. If the paraPac plusTM ventilator experiences continuous flow, remove the ventilator from clinical use, set the device aside for repair and use another device or alternative means of ventilation. Manufacturer action: Instructions.
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