Events

Recall of Philips IntelliVue MX40 WLAN Patient Wearable Monitor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Philips Electronics Australia Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00431-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00431-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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).
  • Action
    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.

Device

Philips IntelliVue MX40 WLAN Patient Wearable Monitor
  • Model / Serial
    Philips IntelliVue MX40 WLAN Patient Wearable MonitorProduct Number: 865352Exchange Part (Service Numbers): 453564615351 TELE PWM,802.11a/b/g,ECG only, ex, non-US453564615371 TELE PWM,802.11a/b/g,ECG&Sp02;, ex, non-USARTG Number: 99204
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DHTGA