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السبت - جمادى الأولى 17, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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SA-03-11-25-1127
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Philips IntelliVue Patient Monitors
الأجهزة المتأثرة
Multiple products, please refer to the attachment.
الممثل المعتمد
Philips Healthcare Saudi Arabia Ltd
سبب المشكلة
In some operation cases , the Alarms of the affected devices had been switched off for an infinite period, and the user may have been unaware that the alarms were off.
الإجراء التصحيحي
Philips is informing customers of the observed errors and related hazards of enabling infinite Alarms Off, including providing instructions on how to configure the device alarm settings. Philips recommends reviewing the configuration of the monitors with infinite Alarms Off functionality enabled and reconfigure settings to require additional confirmation to ensure users are aware of their action when activating infinite Alarms Off, refer to the attachment for the instructions details. For IntelliVue MP5 models only: Philips is developing a software update which will enforce the additional confirmation step when the user enables infinite Alarms Off. To update your MP5 software to include this feature, please reach out to your local Philips representative. Philips is also providing an educational video on this topic, refer to the attachment. Manufacturer's Action: Instructions and Correction.
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