Device product
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Z-0109-2022
Product summary
- Event
- Event 88635
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,169 units
- Official record key
device-enforcement:Z-0109-2022
Official wording
Reason: Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Code information: Software 2.51 and Lower
Distribution pattern: US Nationwide
Derived failure modes
-
Device software or design
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in