Events

Retiro De Equipo (Recall) de Device Recall Remote Patient Monitoring System

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 Vidco, 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
    72794
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0582-2016
  • Fecha de inicio del evento
    2015-11-08
  • Fecha de publicación del evento
    2016-01-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142223
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Causa
    Testing at customer site showed unit remote patient monitoring system mdp2040-0100 in a continuous trap condition, not allowing system to reset and reboot. two customers recently complained of the system freezing and it could only be restarted if the user re-applied power.
  • Acción
    The firm began notifying consignees on Nov. 8, 2015 and followed up with the Advisory Notice letter, dated November 10, 2015. VIDCO identified the root cause and has corrected software that is currently going through validation. This software will be made available for updating the MDP2040-0100 as soon as it is released. The units may be updated on-site with the software program that will become available on the File Transfer Protocol (FTP) site. If you are unable to perform the procedure yourself, VIDCO will assist you in this effort. The current software version can still be used for monitoring as long as the user confirms the displays are still dynamically writing waves to the screen (i.e. waves will be changing in real-time). Consignees with questions can call (503) 641-1804 or 800-638-4326, or send email to sales@vidcoinc.com

Device

Device Recall Remote Patient Monitoring System
  • Modelo / Serial
    Serial numbers: 6533-6537, 6561, 6566-6581, 6539, 6540, 6558-6560, 6562, 6508-6528, 6563-6565, 6529, 6531, 6532, 6541, 6551, 6556, and 6557.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the states of AZ, CA, MD, NM, NJ, and OH.
  • Descripción del producto
    Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. || The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry Step-down and other areas where patient's physiological information are to be observed at one or more locations. Typical information displayed includes ECG and blood pressure waveforms and numeric values which as heart rate and systolic, mean and diastolic pressure. This device acts as the Central Monitor Station, it permits from one (1) to sixteen (16) bedside monitor(s) to be connected simultaneously.
  • Manufacturer
    Vidco, Inc.

Manufacturer

Vidco, Inc.
  • Dirección del fabricante
    Vidco, Inc., 6175 Sw 112th Ave, Beaverton OR 97008-4838
  • Empresa matriz del fabricante (2017)
    Vidco Inc
  • Source
    USFDA