fabian Therapy evolution (2018-12-17)

Starting date:

December 17, 2018

Posting date:

December 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68730

• Reason
• Affected products

Affected products

fabian Therapy evolution

Reason

A manufacturing defect in the front membrane panel overlay could cause the panel buttons to be electrically shorted, thus appearing to the system that the button is being depressed. When this happens, the system will continue to power cycle with alarming. Under the worst circumstances, if the ventilator ceases to deliver positive pressure breaths the patients the patient might experience transient systemic arterial hypercapnia and oxygen desaturation secondary to hypoventilation.

Affected products