Events

Rappel de Device Recall Newport HT50 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
    58612
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2295-2011
  • Date de mise en oeuvre de l'événement
    2009-01-13
  • Date de publication de l'événement
    2011-05-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99708
  • 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 instruments confirmed that the newport ht50 ventilators that were shipped in december 2008 were without the label on the top of the ventilator that reminds users to keep ht50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery.
  • Action
    Newport Medical Instruments, Inc. sent an FIELD CORRECTION letter dated January 13, 2009, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. The Newport HT50 ventilators that were shipped in December 2008, were without the label on the top of the ventilator that reminds users to keep HT50 ventilators plugged into an external power supply whenever possible to preserve the longterm capacity of the battery. The customer were also requested to complete the attached customer REWORK INSTRUCTIONS form and fax it to (714) 427-0489. If you have any further questions, please call (714) 427-5811 x 344

Device

Device Recall Newport HT50 Ventilator
  • Modèle / numéro de série
    Device Listing Number: D0004206 Serial Numbers: N08HT501212491 through N08HT501212523
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-- USA including states of OH, VA, WA, WI and country of Turkey.
  • Description du dispositif
    Newport HT50¿ Ventilator. Model #HT50 H1-B || The device is intended to provide continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. Specifically, the NEWPORT HT50 is applicable for adult and pediatric (i.e. infant, child and adolescent) patients, greater than or equal to 10 kg (22 Ibs), who require the following general types of ventilatory support.
  • 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