Device product
Hamilton Medical Infant Flow Sensor, single use, (1.88m), Part number 155500. The infant flow sensor is an accessory for the Hamilton Medical Ventilators. Product Usage: The infant flow sensor is a device to measure patient air flow and pressures within the Hamilton Medical Ventilators.
Z-1964-2015
Product summary
- Event
- Event 71434
- Status
- Terminated
- Classification
- Class II
- Quantity
- 154 total, all part numbers
- Official record key
device-enforcement:Z-1964-2015
Official wording
Reason: An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.
Code information: PN 155500, all lot codes.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.