
CareFusion · Model Vela Ventilator
Invasive and noninvasive critical care ventilator. Pediatric through adult applications. Advanced settings to treat the most difficult-to-ventilate patient. Multiple noninvasive modes with automatic leak compensation to provide more ventilatory support options. Dual-limb noninvasive ventilation helps eliminate CO2 and rebreathing of exhaled gases.
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Symptoms: Self-test fault, circuit-leak or compliance-check failure, will not be released for use.
Root cause: Patient-circuit / expiratory-valve leak, a flow-sensor fault, an O2-cell fault, or an internal pneumatic fault.
Symptoms: Delivered tidal volume or flow does not match the setting, or fails the annual verification.
Root cause: Flow-sensor drift / contamination, an inspiratory / expiratory valve fault, or a blender / proportioning-valve fault.
Symptoms: Low-supply alarm, FiO2 not matching the setting, O2-cell reads wrong.
Root cause: Wall / cylinder supply issue, an inlet filter / regulator fault, the blender, or an aged O2 cell.
Symptoms: PEEP drifts, auto-PEEP, high-pressure alarms, poor exhalation.
Root cause: Worn or wet expiratory valve / diaphragm, or a blocked exhalation path.
Symptoms: Short internal-battery run time, will not charge, transfers to battery unexpectedly.
Root cause: Aged internal battery or a power-supply fault.
Symptoms: Noisy operation, cannot meet flow demand, turbine / compressor alarm.
Root cause: Worn turbine / compressor.
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Flow sensor(s) | Frequent wear item | $$ | Fairly easy |
| Expiratory valve / diaphragm | Frequent wear item | $$ | Fairly easy |
| O2 cell / sensor | Frequent wear item | $$ | Easy |
| Internal battery | Periodic replacement | $$ | Fairly easy |
| Inlet filters / water traps | Frequent wear item | $ | Easy |
| Turbine / compressor (turbine units) | Major service part | $$$$ | Difficult |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
Synced live from the FDA openFDA API.
CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.
CareFusion has identified a potential risk associated with AVEA ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.
CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions.
The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.
CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
From BioLab, for work done with this kind of equipment.
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