Transmitters And Receivers, Physiological Signal, Radiofrequency

BioButton REF BIOST06040 with Software version 3.0.20

Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.

VistaSolution, physiological signal transmitter. A software graphical user interface for use by healthcare professionals to display physiological data collecte

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 found. A software defect was encountered causing the lack of notification. The defect could result in exposing a patient to potential hypoxia for a short window of time. The firm is correcting the software to bring the performance back into compliance with specifications.

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-00 used with ER920 Wireless Series Arrhythmia Event Recorder.

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 in any patient related injury or present any clinical impact.

Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder.

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. The event did not result in any patient related injury or present any clinical impact.

LS-232 Large 12 LeadWear Single Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardio

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 V-Lead failure, leading to a possible delay in treatment based upon a delay in ECG monitoring.

LS-202 Large LeadWear Combo Pack - Disposable ECG Monitoring component intended for use as a radiofrequency signal transmitter and receiver of electrocardiograp

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 V-Lead failure, intended for use as a radiofrequency signal transmitter and receiver of electrocardiograph physiological signals which are displayed on the ECG monitors of various manufacturers' systems that have been

LifeSync ECG System - Disposable leadwear, Ls-222, Ls-223

When the V-lead is separated from the rest of the lead set, the laminate may tear, exposing the dielectric layer causing a break in the silver ink. If the product is used during a defibrillation after such a de-lamination, it could burn the skin and may compromise the efficacy of the defibrillation.

WMTS Telemetry Receiver, Multiple Patient Receiver, Model Number/ UDI:

Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter.

eCareCoordinator allows the customer to schedule patient tasks (i.e., take weight measurement, take blood pressure).

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 date 14 days later. An error message is generated and forwarded to operations. Subsequently, for days in which no task was generated, patient will not get a reminder on the tablet to take a measurement. If the pa

eCare Coordinator

eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent physiological devices and ancillary systems that are connected either directly or through networks. The software is intended to provide patient information from the patient location through networking technology to a remote care team. A software defect was discovered in the Philips eCareCoordinator (eCC) Clinical User Interface that can at times cause missing or redundant data to be saved without notification to the user.