Events

Rappel de Newport Medical Instruments 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 Nellcor Puritan Bennett Inc. (dba Covidien LP).

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
    68099
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1577-2014
  • Date de mise en oeuvre de l'événement
    2014-04-18
  • Date de publication de l'événement
    2014-05-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126938
  • 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
    Reports of the audible alarm not sounding when the ventilator is in an alarm state. the ventilator, as well as the visual and remote alarms, continue to operate normally.
  • Action
    Newport Medical Instruments, Inc. (Newport), a wholly-owned subsidiary of Covidien is conducting a voluntary field corrective action via letters to be sent during the week of April 28, 2014. The letter titled "URGENT MEDICAL DEVICE FIELD SAFETY CORRECTIVE ACTION" informed customers of the recall by providing: reason for recall, product description, information on affected serial numbers regardless of software versions, issue identified, recommended actions to help mitigate risk to the patient, actions to eliminate the occurrence of this issue, important safety reminders, and contact information. Customers are to contact Technical Support Department to receive a software update kit, and then follow the instructions provided once the kit has been received. The attached verification and completion form should be completed and faxed.

Device

Newport Medical Instruments e360 Ventilator
  • Modèle / numéro de série
    Part Number: SBC2105A. Model Number(s): e360 Ventilator.  Serial numbers N11360719000 through N14360426029.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of Arizona, California, Colorado, Connecticut, Florida, Georgia, Kentucky, Massachusetts, Maryland, Missouri, Nevada, Pennsylvania, Rhode Island, Texas, Virginia, and Washington; and, the countries of Algeria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, England, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Japan, Kazakhstan, Kenya, Lebanon, Liechtenstein, Lithuania, Mexico, Morocco, Namibia, Nepal, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Republic of Armenia, Republic of KOS, Russia, Saudi Arabia, Singapore, Slovenia, S. Africa, Sri Lanka, Taiwan, Thailand, Tunisia, Turkey, UAE, Uruguay, Vietnam, and Yemen.
  • Description du dispositif
    Recalled product is a component of the Newport Medical Instruments e360 || Ventilator: single board computer, part number SBC2105A. || Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency.
  • Manufacturer
    Nellcor Puritan Bennett Inc. (dba Covidien LP)

Manufacturer

Nellcor Puritan Bennett Inc. (dba Covidien LP)
  • Adresse du fabricant
    Nellcor Puritan Bennett Inc. (dba Covidien LP), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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