Class 1 recall: GE Aestiva ventilator-anesthesia machine
GE Healthcare has been recalling a number of combination ventilator-anesthesia machines since April over concerns the devices may overdose patients on inhaled anesthetics, according to a July 11 notice from the FDA.
The affected product line, the Aestiva/5 7900, allows the simultaneous use of two vaporizers. Should both deliver anesthetic gas at the same time, and should the error go unnoticed by clinical staff, patients may die or suffer serious injury due to circulatory shock, FDA explained.
The agency said that, on April 10, GE sent its affected customers an urgent letter describing the issue and instructing provider staff on how to comply with the recall. An FDA enforcement report posted online shows that, as of June 27, no injuries have been associated with the product.
FDA, which did not specify how the problem came to light, also used the notice to encourage patients as well as healthcare professionals to use the agency’s MedWatch system for reporting adverse events or side effects related to FDA-regulated products.
The affected product line, the Aestiva/5 7900, allows the simultaneous use of two vaporizers. Should both deliver anesthetic gas at the same time, and should the error go unnoticed by clinical staff, patients may die or suffer serious injury due to circulatory shock, FDA explained.
The agency said that, on April 10, GE sent its affected customers an urgent letter describing the issue and instructing provider staff on how to comply with the recall. An FDA enforcement report posted online shows that, as of June 27, no injuries have been associated with the product.
FDA, which did not specify how the problem came to light, also used the notice to encourage patients as well as healthcare professionals to use the agency’s MedWatch system for reporting adverse events or side effects related to FDA-regulated products.
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.