Philips Anaesthesia Machines IntelliSave AX700, Dameca MRI 508, Siesta i Whispa, Siesta iTS & Siesta Breasy 의 리콜

Recall

RC-2015-RN-00127-1

Class II

2015-02-23

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00127-1

If the patient is connected to the anaesthesia machine in a volume controlled ventilation mode, and attempts a large spontaneous breath, it is possible for the patient to create a high negative airway pressure, around the same time as a volume controlled breath (mandatory breath).This pressure will be limited by the mechanical negative pressure limiter (npl) valve. the npl valve opens if the patient generates a negative pressure of -5 and -7.5 cmh20 (hpa). this opening pressure of the npl valve is defined at an inspiratory flow rate of 3.5-4.5 l/min. if the patient creates a higher flow rate than 4.5 l/min, the npl valve will continue to function but due to the resistance of the flow and time taken to reach the patient, the airway pressure may decrease further.

Device Technologies is providing an updated addendum (Part Number 453564509701 56 052014) to the IFU and recommendation that "If the patient is breathing spontaneously, support ventilation modes (VSV, PSV) could be considered". This action has been closed-out on 08/08/2016.