Events

Retiro De Equipo (Recall) de Device Recall Newport HT50 Ventilator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Newport Medical Instruments Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58629
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2382-2011
  • Fecha de inicio del evento
    2010-05-14
  • Fecha de publicación del evento
    2011-05-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99738
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Ventilator continuous facility use - Product Code CBK
  • Causa
    The recall was initiated because newport medical has confirmed that the newport ht50 hard shell emergency preparedness (ep) storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time.
  • Acción
    Newport Medical sent an FIELD CORRECTION NOTICE to all affected customers dated May 14, 2010. The letter identified the product, the problem and the action needed to be taken by the customer. Newport Medical also provided a revised labeling for the Emergency Preparedness (EP) Storage Case and an instruction sheet describing where to apply the new labels. Customers were instructed with the information that all the EP storage cases must be relabeled to caution users to follow current labeling guidelines for charging the battery for 8 hours but not longer than 24 hours at any one time. Customers were instructed to complete the attached acknowledgement form and fax it to " Regulatory@NewportMedical.com " Customers with any questions should call Technical Support Department at (800) 451-3111 for US customers, and (714)427-5811 x500 for international customers.

Device

Device Recall Newport HT50 Ventilator
  • Modelo / Serial
    EP Cases are not serialized and are not always associated with a specific ventilator serial number. The field correction applies to all Emergency Preparedness (EP) Storage Cases used to store HT 50 ventilators.
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including states of PA, TX, AK, GA, CA, MD, KY, FL, VA, LA, NC, OK and countries of Canada, Colombia, Armenia and Japan.
  • Descripción del producto
    Newport HT50 Ventilator. || Model No. HT50-H, HT50-HB, HT50-H1, and HT50-H1B. || 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)
  • Manufacturer
    Newport Medical Instruments Inc

Manufacturer

Newport Medical Instruments Inc
  • Dirección del fabricante
    Newport Medical Instruments Inc, 1620 Sunflower Ave, Costa Mesa CA 92626-1513
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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