FDA rates GE ventilator safety guard recall as Class I event

Dive Brief:

GE Healthcare is recalling a series of ventilator breathing accessories in the U.S. after discovering the device has the potential to disconnect from the patient’s breathing circuit.
The recall affects 307 of the CareScape R860 Inspiratory Safety Guard devices, which may have a manufacturing fault that causes the outlet connector to have the wrong dimensions.
While FDA is yet to receive reports of patient injuries associated with the fault, it has deemed the recall a Class I event on the grounds that the problem could lead to loss of oxygen.

Dive Insight:

The inspiratory safety guard plays an important role in the functioning of GE's Carescape R860, a device that provides mechanical ventilation and breathing support to infants, children and adults in healthcare facilities and during transport between sites. The safety guard specifically, which consists of a bi-directional, pleated filter, serves as a mechanism to prevent reverse flow cross contamination.

Recently though, GE discovered that the 15mm female connection port on the safety guards it made from August 2017 to September 2018 may be significantly larger than intended and not meet the ISO conical taper connection standard. The outcome of this manufacturing error is that the device's outlet connector is a poor fit for the breathing circuit, creating the risk that the patient’s airway may disconnect.

GE responded to the discovery by releasing an urgent recall notification letter early in October. FDA has now followed up by categorizing the action as a Class I recall on the grounds of the risk the fault poses to patient safety.

According to the FDA notice, GE is advising its customers to inspect all the safety guards they use. Namely, users should check if the male connector "slides freely up the entire length of the Inspiratory Safety Guard female port." If that happens, the device should not be used without an adapter that corrects for the port sizing error.

GE is asking organizations with safety guards that suffer from the fault to submit a customer response form, and to destroy or return faulty, unused devices.