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الجمعة - محرم 9, 1447
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تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-26-05-25-909
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Newport™ HT70 and Newport™ HT70 Plus Ventilators
الأجهزة المتأثرة
Specific serial numbers of Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. Please refer to the attachment for affected products details.
الممثل المعتمد
Medtronic Saudi Arabia LLC
سبب المشكلة
It has been identified by Medtronic two separate capacitors on one of the ventilator’s Printed Circuit Board Assembly (PCBA), that, in case of failure, may result in one of two distinct outcomes: The ventilator either shuts down during use, thus necessitating the use of an alternate form of ventilation, or the shutdown alert alarm fails to alarm effectively during shut down.
الإجراء التصحيحي
• Review the attachment to determine which of your ventilators or service parts may be affected. • If an affected ventilator or service part is currently in clinical use, remove the device from service and replace it with an alternate means of ventilation, refer to "Patient Management" in the attachment • After completing the transition to the alternate ventilator(s), quarantine all affected ventilators and service parts identified in attachment and follow your facility’s processes and procedures for removal and disposal of the impacted devices. • Provide the attachment to any of your patients using this ventilator in the home care setting to inform them of this safety alert. Manufacturer Action: Instructions and removal.
المرفقات
عودة للقائمة
