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الثلاثاء - رجب 17, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-30-12-25-1202
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Venous Bubble Sensor
الأجهزة المتأثرة
Affected product: BS 3/8x3/32 L1.7 Mat. 701055720 (Bubble Sensor for 3/8” x 3/32” tubing, length 1,7 m) Unique Device Identifier: 04037691816432 All serial numbers are potentially affected.
الممثل المعتمد
Medical Elements Co
سبب المشكلة
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Bubble Sensor. Excessive bending of the cable can lead to poor contact, which may trigger the errors “Ven. bubble sensor defective” or “Ven. bubble sensor disconnected” on the connected medical device (ROTAFLOW II or CARDIOHELP-i). These errors can occur temporarily when the cable is moved or permanently if the connection is fully compromised.
الإجراء التصحيحي
Customers should examine their inventory immediately to determine, if they have any affected product in their inventory. • Upon availability of unaffected replacement products, Getinge will replace customer devices. • Optional for CARDIOHELP-i accessories only: Instead of replacement, the affected accessory may be returned for credit. Upon return of the affected product, please contact your local Getinge representative for credit. • Please refer to the patient management recommendations in the attachment. Manufacturer's action: Instructions and removal.
المرفقات
عودة للقائمة
