Events

Rappel de Device Recall The HAMILTON T1

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 Hamilton Medical 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
    64117
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0741-2013
  • Date de mise en oeuvre de l'événement
    2012-12-19
  • Date de publication de l'événement
    2013-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115383
  • 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
    Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a hamilton t1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
  • Action
    Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Questions should be addressed to Hamilton Medical at 800-426-6331 ext 215

Device

Device Recall The HAMILTON T1
  • Modèle / numéro de série
    Software Versions 1.1.2 and below; Part numbers 161005, 161006.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution including the country of Switzerland.
  • Description du dispositif
    HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. || The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
  • Manufacturer
    Hamilton Medical Inc

Manufacturer

Hamilton Medical Inc
  • Adresse du fabricant
    Hamilton Medical Inc, 4990 Energy Way, P O Box 30008, Reno NV 89502-4123
  • Société-mère du fabricant (2017)
    Hamilton Bonaduz Ag
  • Source
    USFDA