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