Events

Retiro De Equipo (Recall) de Device Recall CSM1901

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 Nihon Kohden America 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
    76723
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1768-2017
  • Fecha de inicio del evento
    2017-03-13
  • Fecha de publicación del evento
    2017-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154033
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Causa
    The pause function on central monitors will not automatically resume when connected to a life scope g9 patient monitor.
  • Acción
    A technical bulletin was issued on March 7, 2017 to make Life Scope G9 users aware of following interaction: the CNS 6201A and CNS 9701A (using the noted software versions) will not Auto Resume when a patient is reconnected to a Life Scope G9 if the patient tile is Paused. Therefore, each time a patient is reconnected to the Life Scope G9, the Pause must be cancelled and monitoring manually resumed on the CNS 6201A or CNS 9701A. A customer letter dated March 13, 2017 was sent to all customers to inform them that Nihon Kohden America (NKA) is voluntarily notifying them that the Pause function on central monitors (models CNS 6201A and CNS 9701A; Software Versions 01-06, 02-10 and 02-40), will not automatically resume when connected to a Life Scope G9 patient monitor (model CSM 1901; versions 01-19, 01-20 and 01-21). Customers are informed of issue,risk to health, and instructions. Customers are instructed to complete the attached reply form and return it to the fax number or email address on the form. Customers with questions are instructed to contact NKA Technical Services Group at (800) 325-0283, Option 6 (M-F, 8am-5pm PDT) or by email at G9@nkusa.com.

Device

Device Recall CSM1901
  • Modelo / Serial
    Lot/Unit Codes: G9 Serial Number: 230 (UDI: 01049319211121682100230) Serial Number: 232 (UDI: 01049319211121682100232)  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-6201A (PU-621RA) with version 01-06, 02-10, or 02-40 software.  Life Scope G9 with version 01-19, 01-20, and 01-21 communicating with CNS-9701A (MU-971RA) with version 01-89 or lower.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide - US Nationwide Distribution including the countries of Germany, Spain, Brazil, Paraguay, Bolivia, Chile, Colombia, Costa Rica, Mexico, Peru, Pakistan, Israel, Qatar, Saudi Arabia, South Africa, Tunisia, United Arab Emirates, Korea, Malaysia, Singapore, Thailand
  • Descripción del producto
    Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CNS-6201A (PU-621RA) and CNS-9701A (MU-971RA).
  • Manufacturer
    Nihon Kohden America Inc

Manufacturer

Nihon Kohden America Inc
  • Dirección del fabricante
    Nihon Kohden America Inc, 15353 Barranca Pkwy, Irvine CA 92618-2216
  • Empresa matriz del fabricante (2017)
    Nihon Kohden Corp.
  • Source
    USFDA