TeleSenseRCM
SCOTTCARE CORPORATION, THE · Model MCT1774 · UDI-DI 00856298006022
Description
The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are: - Cardiology - Pulmonary Care - Home Care - General Practitioners Contraindications: a. Patients with potentially life-threatening arrhythmias who require inpatient monitoring. b. Patients who the attending physician thinks should be hospitalized.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2024-07-19 | Biointellisense Inc. | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| 2021-01-08 | Nihon Kohden America Inc | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| 2020-05-21 | Vitalconnect Inc. | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but no notification was f |
| 2017-05-15 | Boston Scientific Corporation | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
| 2017-03-02 | Philips Visicu | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological device |
| 2016-03-10 | Philips Visicu | The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task is generated for the |
| 2012-02-24 | BRAEMAR, INC. | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor and Fusion device. Th |
| 2011-05-02 | BRAEMAR, INC. | Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The event did not result i |
| 2007-12-13 | Lifesync Corporation | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box failure manifests as a |
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