التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Users to follow the actions provided in the attachments.

Action update (2023-CC-SRC-042 Rev D):
Actions by Philips Respironics: In the October FSN (2023-CC-SRC-042), Philips Respironics had indicated plans for design changes to the BiPAP A40 Pro, BiPAP A30 EFL, and BiPAP A40 EFL. The BiPAP A30 EFL and BiPAP A40 EFL were part of an EFL limited release. These devices were primarily intended for limited distribution and not manufactured or distributed at scale. Now that these activities have concluded, Philips Respironics is conducting a voluntary market removal of all BiPAP A30 EFL and BiPAP A40 EFL devices.

Actions by BiPAP A30 EFL & A40 EFL Device Holders: Contact the Philips Respironics representative specified in this letter for instructions on how to return your BiPAP A30 EFL and BiPAP A40 EFL. 

Action update (2023-CC-SRC-042 Rev E):
The purpose of this updated is to inform users of the guidance from 2023-CC-SRC-039 Revision D (Ventilator Inoperative Alarm condition) which also impacts BiPAP A40 Pro Devices in scope of 2023-CC-SRC-042. As stated in 2023-CC-SRC-039 Revision D the updated notice was to, “clarify the patient population who cannot tolerate interruptions or loss of therapy. For patients who cannot tolerate interruption or loss of therapy, including patients who use a BiPAP A40 Pro device for more than 8 hours a day and/or who are invasively ventilated, an alternative ventilator is required. This determination should be made under the guidance of a physician”.

Action update (2023-CC-SRC-042 Rev F):
Philips Respironics had indicated plans for design changes to the BiPAP A40 Pro, BiPAP A30 EFL, and BiPAP A40 EFL. The BiPAP A30 EFL and BiPAP A40 EFL were part of an EFL limited release. These devices were primarily intended for limited distribution and not manufactured or distributed at scale. Now that these activities have concluded, Philips Respironics is conducting a voluntary market removal of all BiPAP A30 EFL and BiPAP A40 EFL devices. 



Manufacturer action: removal

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-24-06-24-468