التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

1- Devices not experiencing touchscreen issues can continue to be used. The issue, when present, only prevents device start-up and does not affect delivery of therapy once the device is operating. Only use the device for its Intended Use and always adhere to the general user precautions in the Instructions for Use. 

2- If an unresponsive touchscreen occurs, users should first attempt to power the device off, then on again. If this does not resolve the issue, users should contact their Breas Medical authorized service to arrange for a repair.

3- Patients who, after clinical assessment, are deemed at elevated risk of hospital admission or serious deterioration of health without access to a functioning MI-E device may require additional equipment and/or alternative airway clearance methods. 

4- Healthcare providers should test the function of touchscreen on their Clearway 2 devices, and update the device to firmware version 3.1.0 or later, during the next scheduled annual check, and no later than twelve (12) months, in accordance with the Clinician's Manual.

Please refer to the attachment for more details.

Manufacturer's Action: Instruction and Correction

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-13-11-25-1145