Events

Rappel de Newport HT70 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
    58619
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2406-2011
  • Date de mise en oeuvre de l'événement
    2010-09-20
  • Date de publication de l'événement
    2011-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99719
  • 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 because newport medical has confirmed a limited number of power cords recently received from their supplier, glob-tek, have a slightly oversized plug connector which prevents the cord from locking into place. these cords are fully functional as supplied. however, the cord can be easily disconnected. if the cord is disconnected, the ht70 will alert the user with a power di.
  • Action
    Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord. Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.

Device

Newport HT70 Ventilator
  • Modèle / numéro de série
    Serial Numbers: N10HT700810209 - N10HT700810218, N10HT700910219-N10HT700910225
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of MA, PA, OH, IA and Puerto Rico and the countries of Colombia, UAE, Hong Kong, Hungary, India, Japan, Nepal, China, Philippines, Singapore and South Africa.
  • Description du dispositif
    Newport HT70 Ventilator. Model #HT70, || The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Adresse du fabricant
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • 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