Device product
ARJOHUNTLEIGH GETINGE GROUP, RotoProne Therapy System, Model Number 209800
Z-0802-2019
Product summary
- Event
- Event 81872
- Status
- Terminated
- Classification
- Class II
- Quantity
- 231 units
- Official record key
device-enforcement:Z-0802-2019
Official wording
Reason: Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.
Code information: All Serial Numbers
Distribution pattern: US, Saudi Arabia, and Kuwait
Derived failure modes
-
Unknown
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a life-threatening event.