Device product
The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning. Product Usage: Use of the Rotoprone Therapy System is indicated for patients with severe acute respiratory distress syndrome (ARDS). These are critical patients who are at higher risk of cardiac arrest and mortality. Placing a patient in the prone position may reopen collapsed airways and thus improve pulmonary gas exchange and respiratory mechanics.
Z-0926-2014
Product summary
- Event
- Event 67248
- Status
- Terminated
- Classification
- Class II
- Quantity
- 231 units
- Official record key
device-enforcement:Z-0926-2014
Official wording
Reason: The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient
Code information: Model #209500
Distribution pattern: US Nationwide and Middle East
Derived failure modes
-
Unknown
The lock pin can become stuck in the "in" position during the manual rotation, resulting in the inability to prone a patient