Events

Retiro De Equipo (Recall) de Heart Sync C100Physio Radiotransparent Defibrillation Electrodes

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 Heart Sync, 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
    65085
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1434-2013
  • Fecha de inicio del evento
    2013-04-26
  • Fecha de publicación del evento
    2013-05-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117858
  • 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
    Electrode, pacemaker, temporary - Product Code LDF
  • Causa
    On 4/18/13 heartsync became aware of a recall from their wire/connector sub-assembly supplier which is used in the c100-physio electrodes. there were reports of equipment damage due to misalignment from tooling installed in august 2012. the result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.
  • Acción
    HeartSync sent an URGENT MEDICAL DEVICE RECALL notification letter dated April 26, 2013, to all consignees of Heart Sync for C100-Physio Radiotransparent Defrillation Electrodes. On April 29, 2013, an URGENT MEDICAL DEVICE RECALL notification was sent to Vermed Inc for the D304 Defrillation Electrodes . The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the affected product to the firm for full credit. Customers were asked to complete the form and send back via fax to 734-213-5640 or call 734-213-5530. For questions regarding this recall call 734-213-5530. .

Device

Heart Sync C100Physio Radiotransparent Defibrillation Electrodes
  • Modelo / Serial
    Part number : C100-Physio and Lot numbers: Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.
  • Descripción del producto
    Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes || Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
  • Manufacturer
    Heart Sync, Inc

Manufacturer

Heart Sync, Inc
  • Dirección del fabricante
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Empresa matriz del fabricante (2017)
    Heart Sync, Inc
  • Source
    USFDA