Events

Retiro De Equipo (Recall) de Infinity(R) Acute Care System (IACS) Monitoring Solution (M540)

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 Draeger Medical, 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
    60155
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0263-2012
  • Fecha de inicio del evento
    2011-10-18
  • Fecha de publicación del evento
    2011-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-04-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104618
  • 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
    During product training on the infinity(r) acute care system (iacs) monitoring solution (m540) it was discovered that the weight-based drug dosage calculation may indicate incorrect recommended values. in addition, a misalignment of ecg and art waveforms delivered from an infinity(ro acute care system (iacs) monitoring solution (m540) was observed on the infinity central station.
  • Acción
    The firm initiated their recall of this device on October 17, 2011 by issuing a letter to the consignee instructing customers to follow the Instructions for Use and use the Infinity Central Station only for remote assessment of a patient's status. They recommend that you do not consider the waveforms on Infinity Central Station for primary diagnosis purposes. In case of a high priority alarm situation, "Check the patient and treat if necessary". If the misalignment issue is observed, it can be cleared by undocking and redocking the M540 or by changing the order of waveforms displayed on the Cockpit screen (or any other change to the auto display screen layout).

Device

Infinity(R) Acute Care System (IACS) Monitoring Solution (M540)
  • Modelo / Serial
    Catalog number MS25510
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution - IL
  • Descripción del producto
    Infinity(R) Acute Care System (IACS) Monitoring Solution (M540) - Physiological Patient Monitoring Solution || Networked solution/system used to monitor patients' vital signs and therapy, control alarms, review Web-based diagnostic images, access patient records, and scale up functionality based on patient acuity level.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • Dirección del fabricante
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • Empresa matriz del fabricante (2017)
    Stefan Dräger GmbH
  • Source
    USFDA