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تسجيل جديد
السبت - جمادى الآخرة 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-24-11-25-1158
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Accella therapy air mattresses (and spare parts associated with Progressa frames)
الأجهزة المتأثرة
Product Code: P006789A, P006792A, P006793A, P006788A Serial Number: All serial numbers HRPM10022464 to HRPM10029270 UDI-DI Number: 00887761978331, 00887761978409, 00887761978362, 00887761978355 Refer to the attachment for more details about the affected devices.
الممثل المعتمد
Medical Regulations Gate
سبب المشكلة
Technical box cracks that can cause air leaks.
الإجراء التصحيحي
1- If the care provider experiences the error codes listed in the attachment on an affected Accella mattress (or a mattress used with Spare Parts associated with a Progressa frame), please discontinue use of the product until a technical service representative can replace it. If the error code alarms while a patient is on the mattress, please move the patient to an alternative surface. If the error codes do not occur, the mattress is safe to continue use. 2- If the care provider experiences a service indicator light on a stand-alone affected mattress, the light could be one of the error codes. Out of caution, please discontinue use of the product until a technical service representative can troubleshoot the service indicator error. If the service indicator light alarms while a patient is on the mattress, please move the patient to an alternative surface. If the service indicator light does not occur, the mattress is safe to continue use. 3- To correct the issue, Baxter will be sending personnel onsite to replace the technical box of all impacted Accella therapy air mattresses (and Spare Parts associated with Progressa Frames) Manufacturer's Action: Instructions and Correction.
المرفقات
عودة للقائمة
