Events

Rappel de Hamilton C2 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 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
    66408
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0170-2014
  • Date de publication de l'événement
    2013-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-03-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122352
  • 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
    Manufacturer defined limits for improperly functioning loudspeakers of the hamilton c2 alarm system were exceeded.
  • Action
    Hamilton Medical sent an Medical Device Safety Alert and Corrective Action letter dated September 27, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The corrective action does not require any action by the operator. In the case of an alarm situation as described in the letter, users should follow the instruction for use (Section 8 - responding to alarms in the operator manual) and have the ventilator serviced by an authorized service technician. An addendum to the Operators Manual as a result of the field correction was provided to customers with the Safety Alert Letter. Manufacture will develop and provision a test protocol for the service tech which test the proper functioning of the loudspeaker during the annual service inspection. We appreciate your support in this matter and sincerely regret any inconveniences that this action may cause you. We consider this action as necessary to ensure that our customers receive only safe and effective products with high quality. Further questions please call (775) 426-6331 Ext. 210

Device

Hamilton C2 Ventilator
  • Modèle / numéro de série
    Hamilton-C2; Serial numbers from 1000-7100.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including Puerto Rico and the states of IL, MT, IN, ND, AZ, MT, KY, NC, OH, MA, MO, VA, CA, NV, TX, WA, NY, GA, SC,MN, WY, PA, ND, UT, NE, CO and MI.
  • Description du dispositif
    HAMILTON-C2 Ventilator: || Manufactured by Hamilton Medical AG || CH-7402 Bonaduz, Switzerland; || Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 || The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital.
  • Manufacturer
    Hamilton Medical, Inc.

Manufacturer

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