Events

Rappel de Device Recall Anesthesia system

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 Blease Medical Equipment, Ltd..

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
    55177
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1408-2010
  • Date de mise en oeuvre de l'événement
    2010-03-26
  • Date de publication de l'événement
    2010-04-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90223
  • 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
    Potential for delivery of a lower than set concentration of anaesthetic to a patient due to a sticking valve. the lower shuttle may become jammed, not permitting flow of anaesthesia gas through the vapouriser. the vapouriser back bar mounting valves will require exchange only on the systems identified in this matter, no other systems are affected.
  • Action
    On 2/26/2010 notification letters were sent to all international consignees. The 2 domestic consignees were sent notification letters via FEDEX on 3/26/2010. The domestic consignees were also contacted by phone on 3/26/2010. The notification letter is titled URGENT MEDICAL DEVICE CORRECTION. It advises users of the issue and provides additional information which would permit the continued use of the Blease system until replacement back bar valves can be fitted by the recalling firm's service representatives. For users who choose to continue to use the device, the manufacturer recommends the use of an Agent Monitor and user education; also checks that vapourisers have been mounted correctly and the system is leak free, and testing in advance of a procedure. For additional questions, US Customers are directed to call Global Technical Support - +1 425-657-7200 ext: 5089. Non US Customers, call Global Technical Support - +44 1494 784422.

Device

Device Recall Anesthesia system
  • Modèle / numéro de série
    Serial numbers:  Siri 000116, Siri 000885, Siri 001100, Siri 001609, Siri 001610, Siri-001618, Siri-001626, Siri-001637, Siri-001640, Siri-001644, Siri-001658, Siri-001666, Siri-001667, Siri-001668, Siri-001674, AND Siri-001681.  Focu-000735, Focu-000737, Focu-000738, Focu-000739, Focu-000740, Focu-000741, Focu-000742, Focu-000743, Focu-000744, Focu-000745, Focu-000746, Focu-000747, Focu-000748, Focu-000749, Focu-000750, Focu-000751, Focu-100001, Focu-100003, Focu-100004, Focu-100005, Focu-100006, Focu-100007, Focu-100008, AND Focu-100009.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to 2 U.S. hospitals and to customers in the following countries: Panama, Poland, Australia, Singapore, United Kingdom, Bangladesh, Nicaragua, Vietnam, Argentina, Finland, and Columbia.
  • Description du dispositif
    The BleaseSirius and BleaseFocus Anaesthesia Systems.
  • Manufacturer
    Blease Medical Equipment, Ltd.

Manufacturer

Blease Medical Equipment, Ltd.
  • Adresse du fabricant
    Blease Medical Equipment, Ltd., Deansway, Chesham, Bucks, England United Kingdom
  • Source
    USFDA