NightWatch+ US
Livassured B.V. · Model 1.0 · UDI-DI 08719327236086
Description
The NightWatch+ US is a prescription only device that is indicated for use as an adjunct to seizure monitoring of children age 4 till 16 diagnosed with epilepsy having Nocturnal Epileptic Major Motor Seizures which includes tonic-clonic (TC), tonic (if clustered or prolonged >30 seconds), hyperkinetic and TC-like seizures, in home or residential facilities during periods of rest. NightWatch+ US consists of a sensor worn during sleep on the biceps of the upper arm and an alarm station. The sensor consists of a heartrate sensor using PPG (photoplethysmography), a ACC (Accelerometry) movement sensor, and a microprocessor. The microprocessor processes the data from the sensors using a detection algorithm which detects if the sensor readings match pre-programmed parameters that are associated with nocturnal epileptic major motor seizures. When a nocturnal epileptic major motor seizures is detected, the seizure alarm is triggered and transferred from the sensor to the accompanying alarm station which alarms the caregiver by a sound and a blinking LED light. The seizure alarms data can be transferred from the alarm station, using an ethernet connection, to a database in the cloud to be viewed a web-based interface called NightWatch Portal to be able to monitor seizure frequency overtime. The NightWatch+ US is not intended to diagnose specific seizure types.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-13 | EMPATICA SRL | May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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