Philips IntelliVue MX40 WLAN Patient Wearable Monitor 의 리콜

Recall

RC-2017-RN-00431-1

Class II

2017-04-04

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00431-1

An issue has been discovered that under specific 802.11 network conditions, a partial re-association of the mx40 wlan monitor to a compatible central monitoring system (“information center”) is possible. in this state, although the information center provides a visible and audible “no data tele” inop alert, the mx40 wlan itself enters telemetry mode, ie. its screen turns off in one minute and local alarming is disabled. if this issue were to occur while monitoring a patient, it could result in a delay in treatment. to date, phillips has received no complaints involving clinical use that could be associated with this issue.(please note that this issue only involves mx40 wlan monitors, i.E. those operating on a customer-provided 802.11 wireless lan. mx40 monitors with 1.4 ghz and 2.4 ghz smart-hopping radios are not affected).

In the event that, a “No Data Tele” INOP alert is displayed on a Philips IntelliVue Information Center iX (“PIIC iX”), Philips is advising users to check the MX40 as directed in the PIIC iX B.01 IFU (page 87). Users are further advised that if the MX40 is in the Coverage Area, to remove and reinsert the battery. However, if the MX40 is not in the Coverage Area, users are requested to place the sector in the PIIC iX in “standby” as directed in the MX40 B.06 IFU (page 53) or return the patient and MX40 to the Coverage Area. As a permanent solution, Philips is releasing a software upgrade B.06.18 for affected devices and users are advised that a Philips representative will contact affected customers to arrange for the installation of the software upgrade.