Retiro De Equipo (Recall) de Carestation 620, 650 and 650c A1 Anaesthesia devices Carestation

Recall

RC-2017-RN-00640-1

Class I

2017-05-18

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00640-1

Ge healthcare have identified 2 issues with carestation 620, 650 and 650c systems which have the potential for elevated fico2 and unexpected system malfunction.1. an incomplete seal can exist between the disposable absorber and the breathing circuit lower assembly of the carestation 600 series systems. this incomplete seal can allow rebreathing of patient gases that have bypassed the carbon dioxide (co2) absorbent material and could result in unintended elevated inspired levels of co2 (fico2), which could lead to hypercarbia.2. an unexpected transition to a system malfunction state can occur, which will display the following message on the screen: “system malfunction internal problem prevents normal operation. use backup ventilation. to restart, turn power off and on". if the system malfunction is left unresolved, it could result in loss of mechanical patient ventilation, which could lead to hypoxia. to date, there have been no injuries reported to ge as a result of these issues.

GE will arrange for correction of devices. In the interim, the following instructions are provided: 1. If elevated FiCO2 is observed, increasing the flow of fresh gas can reduce the volume of patient gas that could be rebreathed, consistent with standard clinical practices. If the FiCO2 cannot be adequately reduced with this action, consider switching to another anaesthesia device. Use a CO2 monitor whenever anaesthesia is delivered. 2. If unexpected transition to a System Malfunction state occurs: - Manually ventilate patient (move bag-to-vent switch to bag position, adjust APL, increase Oxygen (O2) flow as needed to fill the manual bag), - Monitor patient, - Cycle system power off then on by pressing the power switch twice 5 seconds apart to run the power up self-tests and restore normal operation. Ensure existing pre-use instructions are followed and verify that a method of back-up ventilation, independent of the anaesthesia machine, is available and functional prior to use.