Events

Retiro De Equipo (Recall) de Panorama Patient Monitoring Network

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 Mindray DS USA, Inc., dba Datascope Patient Monitoring.

¿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
    51863
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1401-2009
  • Fecha de inicio del evento
    2009-04-10
  • Fecha de publicación del evento
    2009-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-08-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81474
  • 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
    Physiological Patient Monitor (With Arrhythmia Detection or Alarms) - Product Code MHX
  • Causa
    Software anomaly: software anomaly can occur when the panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.
  • Acción
    Urgent Product Field Correction letters, dated March 27, 2009, were sent by certified mail, return requested, and signature required. The letters identified the affected product and the problem. It also stated the adverse effect on patients and that customers' Panorama software will be upgraded to a current software revision. A Datascope Service Representative will contact customers to arrange for the software upgrade of the Panorama(s) in their facility. This will be done at no cost to the customer.

Device

Panorama Patient Monitoring Network
  • Modelo / Serial
    Software version 8.5.5, 8.5.6, 8.6.1, or 8.7.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA and Australia.
  • Descripción del producto
    Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. || Datascope Patient Monitoring || Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring