Device product
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
Z-0335-2018
Product summary
- Event
- Event 77617
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 176 units
- Official record key
device-enforcement:Z-0335-2018
Official wording
Reason: Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Code information: Serial No. 1000 thru 2090; P/N 951001
Distribution pattern: US Distribution to IL and TX.
Derived failure modes
-
Unknown
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.