Device product
Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Z-0943-2022
Product summary
- Event
- Event 89776
- Status
- Terminated
- Classification
- Class II
- Quantity
- 707 units
- Official record key
device-enforcement:Z-0943-2022
Official wording
Reason: Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
Code information: Trolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity