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الجمعة - رمضان 14, 1446
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أسئلة شائعة
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EN
SA-12-08-24-551
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Airvo 3
الأجهزة المتأثرة
Part Number / Model: PT3YYXX (Note: YY represents the various model codes, XX represents the various country suffixes.) Manufacturing Date Range (YYYY-MM-DD): 2021-03-17 – 2024-03-14 Software Version(s): 1.2.0 – 1.5.1
الممثل المعتمد
Bio Standards LLC
سبب المشكلة
When flow alignment alarm 3.2.2 occurs in Airvo 3 devices set up with High Pressure Oxygen (HPO) and running software version 1.5.1 or earlier, the device will deliver room air only. If this happens, a patient may experience oxygen desaturation that could lead to hypoxia.
الإجراء التصحيحي
Software version 1.5.2 updates the software algorithm and ensures the target therapy continues in the event that this alarm occurs. Until the software is updated, the Airvo 3 device can continue to be used by following "ACTIONS REQUIRED FOR AFFECTED PRODUCT IN YOUR INVENTORY" in the attachment.
المرفقات
عودة للقائمة
