التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

If possible, use a monitor with a battery that is not within the affected battery population listed in the attachment. However, pending correction by GE HealthCare, you can continue to use a monitor with affected batteries by following the instructions below.
1. Whenever possible, monitors with an affected battery should have mains power connected.
2. If you must use a monitor with an affected battery during patient transport:
  a. Prior to use, confirm appropriate battery status by checking that:
    i. No battery failure alarms are indicated on the monitor screen
    ii. Indicator is green representing sufficient charge level
 b. Be aware that the monitor may still shut down during patient transport:
    i. Be prepared to provide alternative methods of assessing the clinical status of the patient until monitor power can be restored
    ii. Bring a mains power cord during patient transport
    iii. Because the CARESCAPE ONE requires connection to either a host monitor or to a F0 / F5 FRAME for mains power, bring a spare battery during patient transport
Please refer to the specific User Manual for instructions for battery status indicators and battery replacement instructions.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-30-09-25-1073