التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Final testing has demonstrated that there are no hazardous levels of formaldehyde when using the EVair Compressor, even at worst-case conditions of
• 40°C (104°F),
• the lowest flow condition of 2 L/min, and
• minimum bias flow.
The restrictions indicated in the previous letter no longer apply. As such:
1. The EVair Compressors can be used to supply air to CARESCAPE R860 ventilators for all patient populations, including neonatal and infant patients (0-2 years of age).
2. The EVair Compressor can be used in a room with maximum air temperature of 40oC (104°F).
EVair 03 (Jun-Air) Compressors:
GE HealthCare has previously communicated End of Service Support for these compressors. If you choose to continue to use these, the instructions provided in the previous letter continue to apply. As stated above, while improper test conditions were also used for the testing that led to the issuance of restrictions for use of these Compressors, since these compressors have not been manufactured for several years, GE HealthCare is unable to conduct testing at appropriate conditions. As such, the restrictions previously communicated in the attached letter (also provided below) still apply to EVair 03 (Jun-Air):
1. GE HealthCare recommends that the EVair 03 (Jun-Air) compressors are not used to supply air to ventilators for neonatal and infant patients (0-2 years of age).
2. GE HealthCare recommends that these compressors are used at a maximum room air temperature of 30oC (86oF).

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-31-12-23-235