Device product
SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).
Z-1134-2021
Product summary
- Firm
- SenTec AG
- Event
- Event 87054
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 devices
- Official record key
device-enforcement:Z-1134-2021
Official wording
Reason: Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.
Code information: Serial Numbers: 303170, 311263, 311166, 311408, 303426* *serial number information current as of today's date
Distribution pattern: IL, PA, FL, NJ, GA, MA
Derived failure modes
-
Unknown
Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.