Patient Application Kit for mature intact skin
SenTec AG · Model PAK-MI · UDI-DI 07640121880964
4
510(k) clearances
16
Adverse events (3 deaths)
3
Recalls
18
Facilities
Description
A combination of single-use products intended to attach the Sentec sensors to conventional measurement sites, recommended for adult, pediatric and neonatal patients with mature/intact skin
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-04-07 | Radiometer America Inc | System shut down-When the TCM Monitor is turned on and the booting process begins, the device stops after the memory count and will not proceed further. |
| 2005-11-01 | Radiometer America Inc | Excessive Drift-the membrane units of the device cause the electrode to exceed performance standards for drift in the first two or more calibrations |
| 2005-02-02 | Radiometer America Inc | Alarm may be silenced- Rapid switching, on and off, of the TCM4 monitor may cause the built-in acoustical alarm to remain silent when tripped. |
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