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تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-24-10-25-1109
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Various Clear-Therm™ Mini HMEF
الأجهزة المتأثرة
Affected products names: • Clear-Therm™ Mini HMEF with luer port • Clear-Therm™ Mini paediatric HMEF with luer port and SuperSet™ catheter mount • Clear-Therm™ Mini HMEF with luer port and elbow • Scented, Strawberry, anaesthetic face mask, size 1, infant, 15M elbow and HMEF • Scented, Strawberry, anaesthetic face mask, size 2, paediatric, 22F elbow and HMEF • Economy, anaesthetic face mask, size 2, paediatric, 22F elbow and HMEF • 15mm Compact™ breathing system with 1 L bag, luer elbow, HMEF, and limb, ≥ 3.0m Please refer to the attachment for more details.
الممثل المعتمد
Mohammed Hamad Abdullah Al Hamad Medical Services Co
سبب المشكلة
The two housings of some HMEF devices have been found to separate when a force is applied during handling of these products or movement and torsion due to repositioning of the patient.
الإجراء التصحيحي
To ensure the safety of patients Intersurgical recommends the following actions are taken in addition to those detailed in the IFU provided with the device. 1. Identify any potentially affected products from the affected codes and lot numbers listed in the attachment. 2. Immediately before use unpack the device and carry out the check as described in the attachment. 3. All users must check the HMEF housing is securely welded by holding both connection tapers at each end and apply a downward breaking force by flexing the tapers in the direction shown by the arrows in the attachment. 4. Retain any affected sample(s) identified, and please report to Intersurgical representative. Manufacturer's Action: Instructions and Removal.
المرفقات
عودة للقائمة
