Events

Rappel de Device Recall Maquet Flowi

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 Cardiovascular Us Sales, Llc.

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
    73137
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0804-2016
  • Date de mise en oeuvre de l'événement
    2015-12-10
  • Date de publication de l'événement
    2016-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-07-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143153
  • 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
    Gas-machine, anesthesia - Product Code BSZ
  • Cause
    Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues. only the model c20 is affected in the us.
  • Action
    Maquet sent "Urgent Medical Device Field Action Field Correction For Flow-i Anesthesia Systems" letters/Field Correction Response forms dated 12/10/2015 via UPS to affected customers. The notification informed customers of the issue, asked them to distribute the notification to appropriate staff; verify the serial number(s) and informed them they could continue to use the system if they were not experiencing electrical issues. Customers were informed that a Maquet service representative would be contacting them to arrange a time to replace their affected units. Customers were asked to complete and return the enclosed Field Correction Response Form to Maquet at FieldActions@maquet.com or by fax to 973.860.1675. If the customer had any related questions they were instructed to contact Maquet Technical Support at 1.888.627.8383 (option 3; option 1; option 1) Monday through Friday between 8:00 am and 5:00 pm EST.

Device

Device Recall Maquet Flowi
  • Modèle / numéro de série
    Model numbers: C20, C30 and C40 (Only Model # C20 for US)  Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400  Serial numbers (2743, 2852, 2854, 2855, 2856, 2858
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide in the states of CA, NY, and OR
  • Description du dispositif
    Flow-i Anesthesia System || Product Usage: || The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration.
  • Manufacturer
    Maquet Cardiovascular Us Sales, Llc

Manufacturer

Maquet Cardiovascular Us Sales, Llc
  • Adresse du fabricant
    Maquet Cardiovascular Us Sales, Llc, 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA