Events

Recall of INTELLIVUE MP20 PATIENT MONITOR SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS 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
    90845
  • Event Risk Class
    II
  • Event Initiated Date
    2014-04-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    On-going monitoring of quality data 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 5-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.

Device

INTELLIVUE MP20 PATIENT MONITOR SYSTEM
  • Model / Serial
    Model Catalog: M8001A (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: M3002A (Lot serial: >1000 NUMBERS CONTACT MFG.); Model Catalog: M8004A (Lot serial: >100 NUMBERS CONTACT MFG.); Model Catalog: M8002A (Lot serial: >100 NUMBERS CONTACT MFG.); Model Catalog: M8102A (Lot serial: >10 NUMBERS CONTACT MFG.); Model Catalog: M8105A (Lot serial: >100 NUMBERS CONTACT MFG.); Model Catalog: M8105AT (Lot serial: >10 NUMBERS CONTACT MFG.)
  • Product Description
    INTELLIVUE MP20 PATIENT MONITOR SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC