Events

Rappel de DatexOhmeda S/5 Aespire Anesthesia System 7100

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 Datex-Ohmeda 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
    33678
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0037-06
  • Date de publication de l'événement
    2005-10-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-04-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42271
  • 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, Anesthesia - Product Code BSZ
  • Cause
    Two conditions may occur with the s/5 aespire anesthesia system. the internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. also the o2 switch may leak or fail.
  • Action
    Urgent Medical Device Correction letter dated 09/23/05 was sent to all customers. The letter describes the issues, affected device serial numbers and recommends that customers DO NOT USE the internal auxiliary oxygen flowmeter, if installed in their system, and to use alternate auxiliary oxygen sources, i.e. wall-mounted oxygen flow meter, in the interim. A GE service representative will contact the customers to schedule an upgrade, performed at no charge.

Device

DatexOhmeda S/5 Aespire Anesthesia System 7100
  • Modèle / numéro de série
    AMXJ00203, AMXJ00204, AMXJ00248 thru AMXJ00257, AMXJ00259, AMXJ00260, AMXJ00262 thru AMXJ00305, AMXJ00308 thru AMXJ00312, AMXJ00317, AMXJ00318, AMXJ00333 thru AMXJ00335, AMXJ00338 thru AMXJ00342, AMXJ00350 thru AMXJ00354, AMXJ00380 thru AMXJ00411, AMXJ00416, AMXJ00419 thru AMXJ00425, AMXJ00429 thru AMXJ00442, AMXJ00451 thru AMXJ00473, AMXJ00485 thru AMXJ00576, ZMXJ00581 thru AMXJ00629, AMXJ00631 thru AMXJ00639, AMXJ00641 thru AMXJ00699
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    CA, CO, FL, GA, IL, IN, MI, MS, NM, OK, PA, PR, SD, UT & WA. OUS to: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Canada, Caribbean, Czech Republic, Chile, China, Colombia, Dominican Republic, Ecuador, Finland, France, Germany, Ghana, Great Britain, Hong Kong, India, Indonesia, Israel, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Oman, Palestine, Peru, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Arab Emerites, Venezuela & Vietnam.
  • Description du dispositif
    Datex-Ohmeda S/5 Aespire Anesthesia System 7100
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • Adresse du fabricant
    Datex-Ohmeda Inc, 3030 Ohmeda Drive, PO Box 7550, zip 53707-7550, Madison WI 53718
  • Source
    USFDA