Events

Retiro De Equipo (Recall) de Philips

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 Childrens Medical Ventures.

¿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
    68226
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1789-2014
  • Fecha de inicio del evento
    2014-04-29
  • Fecha de publicación del evento
    2014-06-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127178
  • 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, apnea, home use - Product Code NPF
  • Causa
    The battery pack wire harness is improperly assembled rendering the device inoperable. the wiring issue causes an error code to be displayed and results in the device sounding an alarm repeatedly at power up. the presence of the error code and the devices alarm prevents the device from functioning until the issue is addressed.
  • Acción
    Philips sent an Urgent Medical Device Correction letter dated April 29, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This Customer Information is intended to inform you about: 1.what the problem is and under what circumstances it can occur 2.the actions that you as a customer can take to minimize the effect of the problem 3.the actions planned by Philips to correct the problem. If you need any further information or support concerning this issue, please contact your local Philips representative: For further questions please call (412) 380-8881. Philips apologizes for any inconveniences caused by this problem.

Device

Philips
  • Modelo / Serial
    989805603611 / 1014557, 989805603631 / 1014559, 989805604511 / 1028969, 989805604521 / 1028970, 989805604531 / 1028971, 989805604631 / 1030271, 989805605051 / 1038140, 989805605061 / 1038141, 989805608801 / U1014557, 989805608811 / U1014559, 989805608831 / U1028969, 989805608841 / U1028970, 989805608851 / U1038140, 989805604231 / 1023384
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including the states of MI, WI, SC, FL, TX, KS, MA, AZ, UT, WV, IN, MN, NV and VA., and the countries of Australia, Belgium and Canada.
  • Descripción del producto
    Philips/Children's Medical Ventures Smart Monitor 2 Professional Series infant apnea monitor.
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • Dirección del fabricante
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA