Events

Rappel de Newport e360 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 Newport Medical Instruments 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
    55504
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1617-2010
  • Date de mise en oeuvre de l'événement
    2010-04-14
  • Date de publication de l'événement
    2010-05-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-08-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91004
  • 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
    The recall was initiated due to a recent increase in complaints related to the early failure of a low pressure transducer which is on printed circuit board (pcb) 2104a in the newport e360 ventilator. ventilators manufactured between september and december 2009 are affected by this field correction. all affected ventilators require the replacement of the pcb2104a board to avoid early failure of t.
  • Action
    The firm, Newport Medical, sent a "Field Correction Notice" dated April 14, 2010, to all customers. The notice describes the product, problem and actions to be taken by the customers. The customers were instructed to: 1) provide your affected customers with a copy of this letter and advise them to pay close attention to pressure errors which can be an early warning sign of the pressure transducer failure; 2) Schedule their ventilators for replacement of the PCB2104A board as quickly as possible to avoid any unanticipated disruption in their use of their product; 3) Contact our Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers) to request the replacement kits you will need; and 4) Complete the attached form and return it to Newport Medical as you complete your PCB2104A replacements. This will allow us to ensure that all affected ventilators have been addressed and close this field action. For questions, customers were instructed to contact Newport Medical Technical Support Department (800.451.3111 for US customers, 714.427.5811x500 for international customers).

Device

Newport e360 Ventilator
  • Modèle / numéro de série
    All serial numbers beginning with N093609XXXXX, N093610XXXXX, N093611XXXXX, and N093612XXXXX
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, KY, NM, NY, UT and internationally to: Armenia, Bolivia, Brazil, Bulgaria, China, Colombia, Ecuador, Egypt, Greece, Hong Kong, India, Malaysia, Mauritius, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Russia, Saudi Arabia, Serbia, South Africa, Sri Lanka, Syria, Taiwan, Thailand, Tunisia, Turkey, UAE, Ukraine, Vietnam.
  • Description du dispositif
    Newport e360 Ventilator || The e360 Ventilator System is intended to provide continuous (endotracheal or tracheostomy [ET] tube) or non-continuous (mask) ventilatory support and monitoring for infant, pediatric, and adult patients requiring tidal volumes equal to or greater than 20 milliliters (mL). The device is for use by prescription only. The intended environments include hospital, hospital-type, and intra-hospital transport environments. Hospital use typically includes general care floors, operating rooms, special procedure areas, emergency rooms, and intensive and critical care areas within the hospital. Hospital-type use includes facilities such as or similar to surgicenters, sub-acute centers, and special nursing facilities outside of the hospital. Intra-hospital transport includes patient transport within the hospital or hospital-type facility.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Adresse du fabricant
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA