Official recall record

Fabian™ HFO Ventilator

What the authority reported

Software V5.2.2 changed the criteria for detecting a patient circuit disconnect during HFO ventilation with the intent to reduce the potential for patient safety-related risks. While ventilating in HFO mode with pressure amplitude (Pamp) > 1.5x mean pressure (Pmean) and with the breathing circuit properly connected, if the breath-by-breath leak monitor exceeds 40%, the ventilator triggers the disconnect alarm. the displayed volume and leak monitors reset to zero and the ventilator reduces the HFOV amplitude as a protection mechanism to prevent lung injury upon reconnection following a true disconnection. If the patient is not disconnected, this results in a small increase in Pmean, and potentially large reduction in amplitude until the alarm is cleared. The potential health risk for a false disconnect alarm occurring that cannot be resolved is inadequate ventilation due to the oscillation being out of range, resulting in hypoxia, hypercapnia, hypoventilation and/or respiratory arrest. Recall start date: April 17, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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