Retiro De Equipo (Recall) de Fukuda Denshi

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 Fukuda Denshi Co., Ltd..

¿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
    78441
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0203-2018
  • Fecha de inicio del evento
    2017-10-16
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    For the fukuda denshi patient monitor model ds-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a short-term battery error message has appeared and has been traced back to a bad (damaged) lithium-ion capacitor (short-term battery backup).
  • Acción
    The recalling firm will notify affected consignees via Field Correction Notification letter. The letter identified the affected product, problem and actions to be taken. A Customer Confirmation Sheet to be filled out by end user and faxed or emailed back to Fukuda Denshi USA, Inc will also be included. For questions call 206-305-4460.

Device

  • Modelo / Serial
    all DS-8100 units manufactured and distributed worldwide.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries
  • Descripción del producto
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N || Product Usage: || Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Fukuda Denshi Co., Ltd., 2-35-8 Hongo, Bunkyo-Ku, Tokyo Japan
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA