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الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-16-04-25-858
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
TEMPUS Pro Patient Monitor
الأجهزة المتأثرة
Tempus Pro Monitors Part Number: 01-1007, 01-1004-R, 00-1007-R, 00-1024-R, 00-1026-R Video Laryngoscope Part Number: 01-2044
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
When a user connects the Video Laryngoscope (VL) to the Tempus Pro Monitor during boot-up, the VL screen is displayed instead of the expected patient details dialog screen. If the user attempts to capture an image (to clear the screen), an error dialog screen is shown that asks the user to restart the device.
الإجراء التصحيحي
Customers/Users can continue to use their Tempus Pro Monitor with the Video Laryngoscope in accordance with the User/Operator Manual and Video Laryngoscope Supplement Guide by taking the following precautions: DO NOT connect the video laryngoscope USB probe to the Tempus Pro during device boot-up. Once ‘Patient Details’ dialog appears, enter patient data then plug in the video laryngoscope USB probe. Philips is updating the Tempus Pro User/Operator Manual and the Tempus Pro Video Laryngoscope Supplement Guide to include the above Warning. Additionally, the video laryngoscope start-up steps will be updated to plug the laryngoscope into either of the two USB ports on the Tempus Pro after boot-up sequence is complete. Manufacturer Action: Instructions and correction.
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