Events

Retiro De Equipo (Recall) de Uterine Electromyographic Monitor

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 MONICA HEALTHCARE 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
    77313
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2588-2017
  • Fecha de inicio del evento
    2017-04-28
  • Fecha de publicación del evento
    2017-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155680
  • 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
    Uterine electromyographic monitor - Product Code OSP
  • Causa
    Monica novii wireless patch system-potential battery damage and excess heat through prolonged charging.
  • Acción
    The recall strategy outlined below addresses the depth of the recall, plan for public notification, and recall notification (customer letter) effectiveness check. This issue will be resolved by sending an Urgent Medical Device Correction customer letter (attached) to customers with affected units. This letter will inform the customer of the issue and provide safety instructions for immediate mitigation of the issue. The long-term solution is to correct all affected Products at no cost to the customer. The plan for public notification is to contact all customers with affected systems by means of an Urgent Medical Device Correction via e-mail. This letter will be sent to the following titles within the affected accounts: Nurse Managers, Labor & Delivery/Bio-medical Engineering Department Managers/Risk Management Directors. We will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures

Device

Uterine Electromyographic Monitor
  • Modelo / Serial
    See attached consignee list for affected device serial numbers.
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The product was distributed thru the United States. Please see attached excel sheet for detailed information about the consignees.
  • Descripción del producto
    Monica Novii Wireless Patch System || product Usage: || Novii Interface - The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected. Novii Pod - The Monica Novii Pod is an intrapartum maternal-fetal monitor that non-invasively measures and displays fetal heart rate (FHR), uterine activity (UA) and maternal heart rate (MHR). The Novii Pod acquires and displays the FHR tracing from abdominal surface electrodes that pick up the fetal ECG (fECG) signal. Using the same surface electrodes, the Novii Pod also acquires and displays the UA tracing from the uterine electromyography (EMG) signal and the MHR tracing from the maternal ECG signal (mECG). The Novii Pod is indicated for use on women who are at >36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.
  • Manufacturer
    MONICA HEALTHCARE LTD

Manufacturer

MONICA HEALTHCARE LTD
  • Dirección del fabricante
    MONICA HEALTHCARE LTD, Interchange 25 Business Park, Bostocks Lane, Nottingham United Kingdom
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA