TRILOGY EVO/O2/EV300 (2021-07-26)

Starting date:

July 26, 2021

Posting date:

August 6, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76161

Last updated:
2021-08-06

• 
  Reason
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  Affected products

Affected Products 

A. TRILOGY EVO

B. TRILOGY EVO, O2

C. TRILOGY EV300

Reason

Correction of the impacted devices is required to address software issues which may result in an increase in the baseline pressure. There are two (2) separate issues which can result in a pressure increase in certain applications of the impacted devices:

Issue 1 - EFS calibration pressure increase

In cases where the infant / pediatric External Flow Sensor (EFS) is used with an active flow or dual limb circuit where a manual circuit calibration is performed, an increase in the baseline pressure can occur.

Issue 2 - Pressure drift (continuous use)

Where target pressure applied to the patient can slowly increase over time with continual uninterrupted use due to a floating-point arithmetic rounding error (~2cmh2o/month). This issue was evaluated separately with consideration to devices intended for home use and those intended for the hospital use.

Affected products