Philips Xper Flex Cardio Patient Monitoring Systems Revisions A and B 의 리콜

Recall

RC-2018-RN-00643-1

Class II

2018-06-05

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00643-1

Philips have identified an intermittent communication issue between the host system and the flex cardio (fc). it is possible for any of the following conditions to occur, which could result in delays in diagnosis or treatment:- boom monitor may not display all active waveform and/or vital sign data- delayed audible and visual alarms at the fc and boom monitor respectively, due to a mismatch between the alarm limits on the host system and the fc/boom monitor- after patient admission and case initiation at the host system, the case may not be fully transmitted to the fc. in this case, the boom monitor in the exam/procedure room will display vital sign data, but the fc will not provide audible alarms- after patient discharge and case termination at the host system, case termination may not be transmitted to the fc. in this case, the boom monitor in the exam/procedure room will continue to display vital sign data, and the fc will continue to provide audible alarms.

Philips are advising the following to reduce the probability of intermittent communication issues: - The Flex Cardio must communicate with its host system via an isolated, dedicated Ethernet port - Do not turn the Flex Cardio device on and/or off while a patient case is open - Verify that the patient name is visible on the Boom Monitor, which is an indication that the patient case has fully transferred and audible alarms are active. Also, if all expected vital signs are not displayed on the Boom Monitor, close and then re-open the case to resynchronize the Flex Cardio and the host system. An addendum to the device’s Instructions for Use will be provided to all affected customers by a Philips representative. Philips will also review the contents of the Instructions for Use addendum with each customer and confirm understanding of the addendum’s contents. Affected customers will also be provided with an updated Software and Documentation Media Kit, which contains the IFU addendum.