Device product
Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation Model Number: 230000 ¿ If the recalled product is a software, include version number: firmware versions 5.0.5 or earlier
Z-1382-2022
Product summary
- Event
- Event 90433
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,113 units
- Official record key
device-enforcement:Z-1382-2022
Official wording
Reason: A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained
Code information: Unique Device Identifier (UDI): UDI 07321822300004. Serial number ranges in scope are: D******, K******, M01**** to M040124, where asterisk (*) denotes a digit from 0 to 9.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained