System, Network And Communication, Physiological Monitors

Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-0

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms)

Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4.

Testing at customer site showed unit Remote Patient Monitoring System MDP2040-0100 in a continuous trap condition, not allowing system to reset and reboot. Two customers recently complained of the system freezing and it could only be restarted if the user re-applied power.

The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancill

A software defect may cause incorrect medication order change. If the user decides to edit the order prior to electronic signature AND selects the return to Previous Screen function, the previously selected medication is replaced with whatever medication is in the number one spot on the complete medication list. At the stage where the order is signed, the medication displayed may be incorrect.

Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115

Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead of a flat line) if Lead 1 or V is being utilized for detecting cardiac arrhythmia.

DPM Central Station

There is a software anomaly with the DPM Central Monitoring System where the trend data of one patient maybe replaced with the trend data of a second patient.

Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8.

Three versions of software for the eCareManager failed to display anticoagulants on the medications screen. The problem arose due to an unexpected change in the National Drug Data File.

DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 ( Datek-Ohmeda Network and iCentral (including iCentral Client)) The Datex-Ohmeda Network and iCentral

The iCentral or iCentral client v5.0.2 with HP xw 4400 and 4600 may spontaneously shutdown, causing monitoring loss at the central monitoring station. Monitoring loss may result in prolonged delay of treatment of potentially lethal arrhythmia.

Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02.

GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) an