Events

Rappel de Device Recall Pulmonetic LTV Series Ventilator

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
    33974
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0186-06
  • Date de mise en oeuvre de l'événement
    2005-11-09
  • Date de publication de l'événement
    2005-11-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-01-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42837
  • 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
    Pulmonetic systems has identified the potential of a printed circuit board malfunction, which can result in a ventilator malfunctio (e.G. vent inop, hw fault, xducer fault) and possibly resulting in failure of the ventilator to breathe for the patient. this malfunction may occur without an accompanying audible alarm.
  • Action
    Urgent Medical Device Recall letter dated 11/09/05 is being sent via certified mail to affected customers. The letter informs customers of the issue. A Pulmonetic Systems representative will contact the customer within 72 hours to schedule a printed circuit board replacement. Customers are advised that in the interim all ventilator-dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction occurs, alternate ventilation can be provided.

Device

Device Recall Pulmonetic LTV Series Ventilator
  • Modèle / numéro de série
    B01117, B01236, B01483, B01637, B01640, B01655, B01802, B01816, B01954, B01974, B01997, B03500-B03524, B03526-B03536
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Within the US to AK, AZ, CA, CO, FL, GA, ID, IL, IN, LA, MI, MO, NE, NJ, NY, NV, OH, OK, OR, PA, SC, TX, UT, VA and WI. OUS to include: Belgium, Brazil, Canada, India, Italy, Korea and United Kingdom
  • Description du dispositif
    Lap Top Ventilator (LTV) Series continuous ventilator, model LTV-900. The LTV-900 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The LTV-900 is a prescription medical device suitable for use in institutional, home and transport settings.
  • 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