Device product
SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer 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-0434-2013
Product summary
- Firm
- Sentec AG
- Event
- Event 63631
- Status
- Terminated
- Classification
- Class II
- Quantity
- 265 boxes (5 per box)
- Official record key
device-enforcement:Z-0434-2013
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: 1D0F, 1D58, 1D80, 1DCA, 1DEA, 1E5F
Distribution pattern: Distributed only in MO.
Derived failure modes
-
Manufacturing or process control
manufacturing defect