Device product
SDMS (SenTec Digital Monitoring System)
Z-0088-2017
Product summary
- Firm
- SenTec AG
- Event
- Event 75257
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 (54 US; 21 =OUS)
- Official record key
device-enforcement:Z-0088-2017
Official wording
Reason: Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).
Code information: SN 306497 to SN 306571.
Distribution pattern: Worldwide Distribution - US Distribution to the states of : LA, MI, MO, OH, TN. and to the countries of : United Kingdom, The Netherlands and Australia.
Derived failure modes
-
Unknown
Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).