Events

Rappel de Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model 950

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 Pulmonetic Systems, 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
    30514
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0294-05
  • Date de mise en oeuvre de l'événement
    2004-11-19
  • Date de publication de l'événement
    2004-12-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-12-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36028
  • 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
    Continuous, Ventilator, Home Use - Product Code NOU
  • Cause
    Reports have been received indicating that the universal cable adaptor, intended to correct an earlier class i recall of ltv series ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.
  • Action
    Beginning November 19, 2004 consignees who received the Universal Cable Adaptors (UCA) as correction to the voluntary November 1, 2004 Class I Recall were notified by telephone to discontinue installation of adaptors in stock. A Universal Cable Adaptor Recall Notification will be distributed by Certified Mail on or about November 30, 2004 providing instruction to remove the UCA and instruct consignees to follow November 1, 2004 recall interim instructions. Additionally, all consignees will receive instructions (on December 7, 2004) on how to return any device affected by the November 1, 2004 Recall for a power board replacement at a Pulmonetic systems, Inc. authorized service center.

Device

Device Recall Pulmonetic System Universal Cable Adaptor for use on LTV Series Ventilator, Model...
  • Modèle / numéro de série
    all Universal Cable Adapters identified on outer packaging as part no. 17820-001 and distributed between 11/02/04 and 11/08/04.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    throughout the United States and to countries such as Germany, Canada, United Kingdom, Australia and Japan
  • Description du dispositif
    Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)
  • Manufacturer
    Pulmonetic Systems, Inc.

Manufacturer

Pulmonetic Systems, Inc.
  • Adresse du fabricant
    Pulmonetic Systems, Inc., 17400 Medina Rd Ste 100, Minneapolis MN 55447-1341
  • Source
    USFDA