Events

Rappel de Servos Ventilator Systems

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 Maquet 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
    58793
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2629-2011
  • Date de mise en oeuvre de l'événement
    2011-04-20
  • Date de publication de l'événement
    2011-06-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100306
  • 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
    Ventilator, continuous, facility use - Product Code CBK
  • Cause
    Through customer complaints, maquet has been informed that servo-i ventilators have stopped to ventilate and have generated three different technical error codes.
  • Action
    Maquet Inc. sent an URGENT DEVICE SAFETY ALERT letter dated April 20, 2011, to all affected customers via Federal Express. The letter identified the product, the problem and the action needed to be taken by the customer. The letter informs the user of the issue and provides additional instruction and how the existing manual should be updated. Customers are asked to fill out the attached response form and fax it to 1-973-807-9210. The following warning will be included in all user's manuals delivered with new ventilators: 'Warning ! The Servo-i Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction. Warning! The Servo-s Ventilator System is not intended to be used during radiotherapy, since this may cause system malfunction.' Additionally the warning stated above will be included in the format of a sticker with the yearly preventive maintenance kit for Servo-i and SErvo-s to update exiting User's manuals for the installed base of Servo-i and SErvo-s ventilators. A maintenance report form will also be included in the kit which serves as an acknowledgement from the user that the sticker has been added to an affected ventilator unit's operating manual. For further questions, please call (973) 709-7660.

Device

Servos Ventilator Systems
  • Modèle / numéro de série
    Article number 66 40 440; all units
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide)
  • Description du dispositif
    Servo-s Ventilator Systems; Article number 66 40 440. || Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory insufficiency; these are only to be used by healthcare providers in hospitals or healthcare facilities and for in-hospital transport. These are not to be used with any anesthetic agents.
  • Manufacturer
    Maquet Inc.

Manufacturer

Maquet Inc.
  • Adresse du fabricant
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA