Device product
SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane Changer is indicated for use with the V-Sign Sensor only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension, oxygen saturation, and pulse rate are required for adult and pediatric patients.
Z-0433-2013
Product summary
- Firm
- Sentec AG
- Event
- Event 63631
- Status
- Terminated
- Classification
- Class II
- Quantity
- 195 boxes (9 per box)
- Official record key
device-enforcement:Z-0433-2013
Official wording
Reason: A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.
Code information: Lot numbers: 1CF5, 1D21, 1D60, 1DC6, 1DED, 1E0D
Distribution pattern: Distributed only in MO.
Derived failure modes
-
Manufacturing or process control
manufacturing defect