Events

Rappel de Device Recall IntelliVue Clinical Information Portfolio

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 Philips Healthcare Inc..

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
    59297
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3111-2011
  • Date de mise en oeuvre de l'événement
    2011-07-08
  • Date de publication de l'événement
    2011-08-31
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102145
  • 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
    Display, cathode-ray tube, medical - Product Code DXJ
  • Cause
    Under certain circumstances, edits to an order can result in unintended scheduled interventions on the intellivue clinical information portfolio. a patient may receive interventions or additional medication doses that are not intended.
  • Action
    Philips Healthcare sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated July 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers are asked to follow the guidelines in the "Action to be taken by Customer/User" section of the Urgent Medical Device Correction Notice. Philips has developed a software upgrade to address this problem in the short term. This upgrade will be available immediately. This software upgrade will be performed by Philips service personnel. While customers await the correction of their devices, customers are instructed to follow the instructions for use for the device, which includes the directions to: 1. Always use the medication administration record (MAR) in determining patient care. 2. Always review orders and pending administrations in the administration record after any changes to an order are stored. For the longer term, Philips is developing safeguards intended to minimize the potential for similar errors resulting from order changes and upgrade to be available in September 2011. If you need any further information or support concerning this issue, please contact your local Philips representative.

Device

Device Recall IntelliVue Clinical Information Portfolio
  • Modèle / numéro de série
    Software version: D.03, E.0, or E.01 of the software
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CHINA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY HONG KONG, IRELAND, ITALY, KENYA, LATVIA, MALAYSIA, NETHERLANDS, NORWAY, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA, THAILAND, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • Description du dispositif
    Philips Medical: || 865047 IntelliVue Clinical Information Portfolio Release D.03 || 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 || 865300 IntelliVue Clinical Information Portfolio NICU Link || Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage.
  • Manufacturer
    Philips Healthcare Inc.

Manufacturer

Philips Healthcare Inc.
  • Adresse du fabricant
    Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA