Device product
Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.
Z-0905-2014
Product summary
- Event
- Event 66835
- Status
- Terminated
- Classification
- Class II
- Quantity
- 242 devices
- Official record key
device-enforcement:Z-0905-2014
Official wording
Reason: The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.
Code information: lowest serial number is GN001141; the highest is GN001704 (non-consecutive)
Distribution pattern: Nationwide Distribution including CA, MO, PA, NJ, NY, OH, VA, TX, NC, DE, KS, TN, LA, IL, MI, SC, WI, and FL.
Derived failure modes
-
Unknown
The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.