Device product
HAMILTON-H900 Humidifier, Models: 950001, 950004
Z-1385-2022
Product summary
- Event
- Event 90460
- Status
- Completed
- Classification
- Class III
- Quantity
- 203
- Official record key
device-enforcement:Z-1385-2022
Official wording
Reason: When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.
Code information: UDI:07630002801546. All devices with software version 1.10c
Distribution pattern: US: WI, FL, CA, NV, PA, TX, PA
Derived failure modes
-
Unknown
When starting a humidifier, intended for respiratory gas conditioning during invasive and noninvasive mechanical ventilation, with an empty chamber, and water is not filled into the chamber, the low water level alarm will be delayed and medical staff are unaware that there is no water in the chamber.