V60 Ventilator, Symbols Only, with C-Flex and Avaps Option (2020-03-12)

Starting date:

March 12, 2020

Posting date:

April 24, 2020

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-72847

Last updated: 2020-04-24

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  Reason
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  Affected products

Affected Productts

V60 Ventilator, Symbols Only, with C-Flex and Avaps Option

Reason

A solder connection on the power management printed circuit board assembly (PCBA) of affected V60 ventilators is subject to solder connection failure. This solder joint connects a component (designated as R31) to the PCBA.

In the most common failure mode of the solder joint (estimated to be less than 1 in 650 of affected devices), the failure will cause the blower to lose power, spool down, and trigger a visual and audible high priority ""check vent"" alarm to alert clinicians to switch the patient to alternative ventilation. This failure mode is referred to as an ""open failure.""

A significantly less common failure mode was identified in which the solder experiences an intermittent connection. The intermittent connection disrupts expected operation and triggers the unit to shutdown unexpectedly. Should this intermittent failure occur, the ventilator will shut down without issuing an alarm.

Affected products