Events

Rappel de Masimo SET uSpO2 Cable

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Masimo Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    69504
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0213-2015
  • Date de publication de l'événement
    2014-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130772
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Oximeter - Product Code DQA
  • Cause
    Firm has identified a small number of oximetry cables with crossed-internal wires. the effect on performance when these wires are crossed is that when a low spo2 value is measured, a high spo2 value would be displayed on the monitoring device. additionally when a high spo2 value is measured, a low spo2 value would be displayed on the monitoring device.
  • Action
    An "Urgent: Advisory Notice," dated 09/30/2014, was sent to customers. The letter informed customers of the problem identified and the actions to be taken. Customers were instructed to evaluate their inventory of Oximetry Cable(s) using the following method: Use the Oximetry Cable to take a SpO2 measurement on a healthy individual with an expected SpO2 value above 90% or review SpO2 measurements take with the Oximetry Cable and verify that measurement results were consistent with expected SpO2 values. If the SpO2 measurement(s) is consistent with expected SpO2 value, the Oximetry Cable is not affected and can continue to be used. Customers are instructed to complete and return Attachment 2, Tracking/Verification Form, to Masimo in order to document that the Oximetry Cable(s) is functioning as intented. If the assessment results in SpO2 measurement that is not consistent with expected SpO2 value, then the Oximetry Cable should be removed from service, segregated and returned to Masimo. Customers are instructed to call 1-800-326-4890 and select option 2 for Technical Services. Customers are to determine with Technical Services whether they will return the affected Oximetry Cable(s) to Masimo for replacement or refund. If returning for replacement customers are suppose to obtain a Return Material Authorization Number (RMA number).

Device

Masimo SET uSpO2 Cable
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution including; nationwide (U.S. and Puerto Rico) and the countries of Argentina, Austria, Brazil, Canada, China, Denmark, France, Gernany, Hong Kong, India, Italy, Japan, Jordan, Kuwait, Mexico, Netherlands, Poland, Portugal, South Korea, Spain, Switzerland, Turkey, and United Kingdom.
  • Description du dispositif
    Masimo SET uSpO2 Cable || The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. || Shipping/Package: All Pulse Oximetry cables are shipped non-sterile in a cardboard carton. They are intended to be used non-sterile.
  • Manufacturer
    Masimo Corporation

Manufacturer

Masimo Corporation
  • Adresse du fabricant
    Masimo Corporation, Forty Parker, 40, 50 & 60 Parker, Irvine CA 92618
  • Société-mère du fabricant (2017)
    Masimo Corporation
  • Source
    USFDA