Events

Safety Alert Or Field Safety Notices for Rad-8 Pulse Oximeter with 20-pin patient cable connector

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Masimo.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/043
  • Event Number
    CON286952
  • Date
    2013-06-20
  • Event Date Posted
    2013-06-20
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286952?tabName=allTabs
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Risk of delay in treatment. some rad-8 pulse oximeters turn off when they are moved, without the operator pressing the power button. the manufacturer has issued a field safety notice (dated 08 march 2013) to each customer listing specific affected serial numbers.
  • Action
    Stop using and quarantine these pulse oximeters. If no alternatives are available, check that the pulse oximeter is still turned on whenever it is moved. Contact the manufacturer to arrange for the repair of affected devices and return the completed tracking/verification form to the manufacturer.

Device

Rad-8 Pulse Oximeter with 20-pin patient cable connector
  • Model / Serial
  • Product Description
    Rad-8 Pulse Oximeter with 20-pin patient cable connector. Manufactured from 27 March 2009 to 24 January 2013 inclusive. Specific serial numbers are affected.
  • Manufacturer
    Masimo

Manufacturer

Masimo