qube Compact Monitor & XPREZZON Bedside Monitorqube Compact Monitor shipped between 16 December 2013 and 15 December 2014 의 리콜

Recall

RC-2015-RN-00104-1

Class II

2015-02-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00104-1

Spacelabs healthcare has received multiple reports regarding the following: - a failure to boot following power on or reset, resulting in monitor operation.- loss of network connectivity, which may result in;- an inability to display alarms and data from the affected monitor on central stations and other bedside monitors, or- a failure to transmit parameter and alarms from the affected monitor to system printers and sapcelabs’ intesys clinical suite retrospective database (including the clinical events interface remote notification feature).- display of english language when previously configured for another language (the alarm messages displayed in the parameter waveform zone are not affected as these are stored on a command module and not on the monitor.- touchscreen failure where touching the screen does not produce the expected response.This issue is caused by inadequate electrical contact on one of the printed circuit board assemblies.

A small number of printed circuit boards with the affected socket were also distributed to customers to facilitate repair of customer monitors. Medtel Pty Ltd will contact affected customers to schedule a convenient time to replace the PCBAs in in their facility. Meanwhile customers are advised the following: - The reported issues occur mostly at initial power on of a monitor. Always check for proper operation (such as functionality of touchscreen, proper language, and network connectivity) when the monitor is first turned on. - If the product is monitored via a central station, ensure the notification feature for monitoring communication loss is on. The capability is on by default. - If a bedside monitor is not monitored via central station, check the bedside monitor frequently to ensure the display is functional. - Do not rely solely on the monitor for critically ill patients. This action has been closed-out on 05/08/2016.