Developers: | GE Healthcare |
Date of the premiere of the system: | February, 2020 |
Branches: | Pharmaceutics, medicine, health care |
2020: A withdrawal of the rejected systems
At the beginning of February, 2020 GE Healthcare withdraws a number of the systems of Carestation anesthesia in the USA because of a problem which can become the reason of a stop of artificial ventilation of the patient.
The systems of GE Healthcare Carestation anesthesia are used for providing the general inhalation anesthesia and support of breath (artificial ventilation of lungs) at children and adult patients. The systems of anesthesia are used everywhere in hospital and the surgical centers.
Regulatory bodies report that in A1 Carestation 620/650/650c models trib-in cable connection can be broken. Such situation is capable to lead to the termination of artificial ventilation of the patient and to threaten his life. In a similar case a system should give sound and visual alarms to warn the medic about a neipravnost and to suggest it to switch to other ventilation system or to begin manual ventilation of the patient. Otherwise the patient is threatened by a hypoxia, damage of fabrics or bodies and a lethal outcome.
In November, 2019 GE Healthcare sent to clients of the letter with warning of this problem and provided a number of recommendations. The producer suggested clients to continue use of a system prior to a visit of the representative of GE Healthcare which should check the mechanism and correct a problem. If a system gives an alarm and suggests to pass to manual ventilation, medics should replace immediately the Carestation system with an alternative ventilation system or to begin artificial ventilation of lungs manually. Hospitals should carry out routine maintenance of systems at least once a year.
The company withdraws 3599 Carestation systems made during the period from August, 2018 to July, 2019. Regulatory bodies report that by February, 2020 there are no victims.[1]