Events

Recall of Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors

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-2014-RN-00514-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00514-1
  • 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
    On-going monitoring of quality data by the manufacturer has determined that the risk of battery failure increases with age, when a battery remains in use longer than 3 years after the date of manufacture or 500 charge-discharge cycles. such failure may result in overheating. battery management and safety practices information for the batteries m4605a / m4607a are not clearly documented in the instructions for use for intellivue patient monitors with software releases up to and including g.0. overheating of the battery may cause the battery to ignite or explode, which may result in injury to a patient or user.
  • Action
    Philips is initiating this correction to provide an Addendum to the Instructions for Use for IntelliVue Patient Monitors with software releases up to and including G.0. The addendum describes that batteries M4605A / M4607A should be replaced after 3 years of continuous use after date of manufacture or 500 battery charge-discharge cycles. The addendum to the IntelliVue Patient Monitor IFU is included with the customer letter. This action has been closed-out on 10/02/2016.

Device

Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient Monitors
  • Model / Serial
    Lithium Ion Batteries, M4605A and M4607A for use with IntelliVue Patient MonitorsModel numbers of the affected patient monitors :MP2, X2, MP5, MP20, MP30, MP40, MP50Product numbers: M3002A, M8102A, M8105A, M8105AT, M8001A, M8002A, M8003A, M8004AARTG Number: 94238
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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