Events

Alerte Ou Avis De Sécurité sur Rad-8 Pulse Oximeter with 20-pin patient cable connector

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Masimo.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/043
  • Numéro de l'événement
    CON286952
  • Date
    2013-06-20
  • Date de publication de l'événement
    2013-06-20
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON286952?tabName=allTabs
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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