Events

Recall of Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)

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-2015-RN-00077-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00077-1
  • 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
    Philips is informing that a software defect has been identified that involves the use of the “change bed label” feature at the information center ix. if the configuration for this item is set to “optional” and a user selects the “location” button within the “manage patient” menu and makes a change to the patient location, alarms for sp02 and/or non invasive blood pressure (nbp) will become disabled without visual notification (bell with an “x”) to the user. this problem only happens when the patient is monitored using a networked intellivue trx telemetry m4841/trx4851a patient worn device (pwd).
  • Action
    Philips is providing instructions to the users to prevent this issue from occurring: Customers/users should: 1) Disable the Change Bed Label field in Patient Management. This is accomplished by changing the feature from ‘Optional to ‘Hidden’ 2) All patient transfers must be performed using the Transfer key in the Manage Patient application. Philips is providing a software correction to customers with impacted devices at no charge. This action has been closed-out on 08/08/2016.

Device

Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)
  • Model / Serial
    Philips IntelliVue Information Center (PIIC) iX system (A Centralized Patient Monitoring System)Part Numbers: 866023 (IntelliVue Info Center iX), 866024 (PIIC iX Upgrade), 866117 (PIIC Classic Upgrade)Serial Numbers: Release A.00, A.01 and A.02 versions in use with M4841A/TRx4851 telemetry devicesARTG Number: 94237
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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