The device was returned to resmed and an initial evaluation confirmed the reported insufficient tidal volumes.Analysis of the device error logs revealed occurrences of system failure 21/13 related to the motor.Dust contamination was visualized at the filter, filter cover, inlet assembly, flow meter and pneumatic block.The investigation conclusion is not finalized at this stage.If more information becomes available, a supplemental report will be submitted.The stellar 150 device user guide provides the following indications for use: - ¿the stellar 100/150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (13kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea.¿ the user guide also provides the following contraindication: - ¿the stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar is not a life support ventilator.¿ resmed reference#: (b)(4).
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It was reported to resmed that a patient experienced respiratory exhaustion, tachypnea, discomfort, suffocation, hypercapnic respiratory acidosis and severe malnutrition allegedly due to "turbine failure" of a stellar 150 device with insufficient tidal volumes delivered and absence of alarm of the failure.The patient was hospitalized for re-evaluation of ventilator settings and observation of patient.The patient was removed from the device and placed on an astral device after which there was rapid improvement in patient condition.
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