Health product recall

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

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

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

Lot or serial number

Not applicable.

Model or catalog number

1053614

Companies
Manufacturer

Respironics California Inc.

2271 Cosmos Court

Carlsbad

92011

California

UNITED STATES