Carescape R860 (ventilator)

2024: GE HealthCare ventilators cause chemical poisoning

On January 9, 2024, the U.S. Food and Drug Administration (FDA) reported that certain GE HealthCare ventilators (IVLs) equipment during operation could release potentially hazardous chemicals. This creates a risk of breathing problems and poisoning in patients.

The problem is related to the EVair and EVair 03 (Jun-air) compressors. The first is designed to supply compressed air for the Carescape R860 ventilator, which can be used, among other things, for intensive care of newborns. The nCPAP mode, in which frequency and pressure can be adjusted, provides non-invasive respiratory support and prevents the need for intubation. In turn, the EVair 03 device is designed to work in conjunction with the Engström Carestation/Pro expert class device for adults, children and newborns.

Carescape ventilator R860

It has been reported that elevated levels of formaldehyde may be observed using these equipment. This substance even in low concentrations irritates the skin, eyes and nasopharynx. Exposure to formaldehyde, as noted in the FDA notice, can lead to neurological disorders or breathing problems, including asthma, decreased lung function, inflammation, and other negative effects. This is especially true for newborns and infants "who may have immature lung function or other comorbidities."

GE HealthCare continues to assess the root cause of elevated levels of the chemical and is working with the FDA to conduct additional testing. As of mid-January 2024, there are no reports of any adverse events in patients associated with this problem. However, GE HealthCare recommends that healthcare facilities not use EVair and EVair 03 compressors when providing therapy in newborns and infants.^[1]

2022: GE Healthcare recalls defective batteries for ventilators

GE Healthcare recalls defective Carescape R860 ventilators batteries on June 28, 2022. The U.S. Department of Health and Human Services awarded the recall Grade I, the most serious.

GE Healthcare has recalled backup batteries of the Carescape R860 ventilator, including spare batteries, as batteries can run out early. If the ventilator is battery-only when the battery fails, ventilation can stop completely, preventing the user from receiving oxygen and breathing support.

GE Healthcare recalls defective batteries for ventilators

Carescape R860 uses the main AC power supply through a wall plug for operation, but has a backup battery designed to keep the device running for MECHANICAL VENTILATION a certain time if the main AC power supply is not available. An example of such a case would be patient transport. Spare backup batteries are available for use when the original backup battery expires.

This problem can potentially cause a lack of oxygen (hypoxia), especially if it occurs over a long period of time, which can lead to serious injury and death. In connection with the use of the device, 1,553 complaints, one injury and zero deaths were registered.

The recall affected 4,222 devices in the U.S., all distributed between April 2, 2019 and April 18, 2022, according to a notice from the U.S. Department of Health and Human Services. The company initiated the recall on April 18, 2022.

GE Healthcare sent an urgent medical device remediation letter to customers recommending that users conduct a battery health check immediately after receiving the remediation letter, every three months and before use if the device was in storage for more than three months.

Users were also instructed to continue using the affected ventilators while the device is connected to an AC mains power source supported by backup emergency power. If the use of a battery ventilator is necessary, for example, during transportation, when alternative possibilities are limited, users should follow standard clinical practice when carrying out appropriate easily accessible alternative ventilation, for example, a bag-valve system.

Batteries should be replaced as needed before using the patient, and the ventilator should remain connected to the main AC power supply when not in use, even when stored, to prevent battery discharge and degradation. Reserve batteries should be replaced at least once every three years.^[2]

Notes