103164 tCOM+
SenTec AG · Model 103164 · UDI-DI 07640121880995
1
510(k) clearances
114
Adverse events (4 deaths)
12
Recalls
56
Facilities
Description
The Sentec patient monitor, model tCOM+, is a portable stand-alone patient monitor indicated for continuous, non-invasive patient monitoring of carbon dioxide partial pressure (PCO2), oxygen partial pressure (PO2), functional oxygen saturation (SpO2) and pulse rate (PR), using either: • a single, digital sensor (V-Sign™ Sensor 2) for PCO2, SpO2 and PR measurement, OR • a single, digital sensor (OxiVenT™ Sensor) for PCO2, PO2, SpO2 and PR measurement PO2 measurement with tCOM+ is only possible when used in combination with an OxiVenT™ Sensor.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2023-05-19 | GE Healthcare Finland Oy | There is a potential reduction of energy reaching patient during defibrillation, potential contact with unintended voltage, or inaccurate measurement. |
| 2011-04-08 | GE Healthcare, LLC | The plastic enclosure on the external power supply of the TruSat Pulse Oximeter is prone to breakage, and overheating. The issue may impact patient or user safety. Potential for s |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.