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Fabian™ hfo ventilator
Official notice
24 May 2024
Last checked
24 May 2024
An official Health Canada notice concerns Fabian™ hfo ventilator. 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 Published 2024-05-24.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75560
Official notice
2024-05-24
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Acutronic Medical, Fabian™ Hfo Ventilator.
Source & status
Source & status
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Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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