Events

Rappel de DatexOhmeda S/5 Anesthesia Delivery Unit

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 GE Healthcare.

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
    50800
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1635-2009
  • Date de mise en oeuvre de l'événement
    2008-10-30
  • Date de publication de l'événement
    2009-07-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77328
  • 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 for Anesthesia - Product Code BSZ
  • Cause
    Ge healthcare has received reports of breathing circuit or tubing misconnections of the anesthesia delivery unit (adu), that may impact patient safety.
  • Action
    A GE Healthcare "Urgent Medical Device Correction" letter was sent to consignees on 1/16/09. The letter was addressed to Health Care Administrator, Chief of Anesthesia and Director of Clinical Engineering. The letter described the Safety Issue; Affected Product Details; Safety Instructions, which include clinical personnel being properly trained on the correct connections of breathing circuit tubing and proper execution of System Checkout according to the ADU URMs; Product Correction and Contact Information.

Device

DatexOhmeda S/5 Anesthesia Delivery Unit
  • Modèle / numéro de série
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA including states of AL, AK, AZ, AR, CA, CO, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, and WI and countries of Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia & Herzegovina, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, England, Estonia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Iraq, Ireland, Isle of Man (UK), Israel, Italy, Japan, Jordan, Kazahkstan, Kuwait, Latin America, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Yemen.
  • Description du dispositif
    Datex-Ohmeda S/5 Anesthesia Delivery Unit || Intended to provide general inhalation anaesthesia and ventilatory support to a wide range of patients. Intended for volume or pressure control, pressure support and synchronized intermittent mandatory (SIMV) ventilation modes.
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare
  • Adresse du fabricant
    GE Healthcare, 9900 Innovation Drive, Wauwatosa WI 53226
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA