Events

Retiro De Equipo (Recall) de Device Recall Syncardia

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 SynCardia Systems 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
    63915
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0620-2013
  • Fecha de inicio del evento
    2012-12-05
  • Fecha de publicación del evento
    2012-12-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-06-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115005
  • 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
    pacemaker battery - Product Code DSZ
  • Causa
    Syncardia systems is recalling the companion external batteries used with the companion 2 driver system because they may potentially be at risk of thermal events and/or other physical damage such as melting, charring and/or burning.
  • Acción
    Syncardia Systems sent a" Urgent Field Safety Notice" dated December 10, 2012, to all affected customers. The letter identified the product the problem and what action the customer needs to take.. The letter informed the customers that there were 3 reported thermal battery events (2 of which occurred on-site at either SynCardia or at the battery manufacturer, Dow Kokam, and one incident that occurred in the field) which caused physical damage to the batteries including burning and/or charring. The batteries were not in use with a patient at time of the reported issue, and there were no reports of any adverse impact to any patient or user. Customers are instructed to follow the directions on the attached Return page, and return their customer response form to SynCardia as soon as possible. Customers with questions are instructed to call (520) 545-1234 or (520) 440-7593.

Device

Device Recall Syncardia
  • Modelo / Serial
    Serial # Lot#  00067 11/12  00071 11/12  00073 11/12  00076 11/12  00079 11/12  00085 11/12  00086 11/12  00087 11/12  00089 28/12  00091 28/12  00092 28/12   00093 28/12  00094 28/12  00095 28/12  00098 28/12  00099 28/12  00101 28/12  00102 28/12  00103 28/12  00104 28/12  00105 28/12  00106 28/12  00107 28/12  00108 28/12  00109 28/12  00110 28/12  00111 28/12  00112 28/12  00113 28/12  00114 28/12  00115 28/12  00116 28/12  00117 28/12  00118 28/12  00119 28/12  00120 28/12  00121 28/12  00122 28/12  00123 28/12  00124 28/12  00125 28/12  00126 28/12  00127 28/12  00128 28/12  00129 28/12  00130 28/12  00131 28/12  00132 28/12  00133 28/12  00134 28/12  00135 28/12  00136 28/12  00137 28/12  00138 28/12  00139 28/12  00140 28/12  00141 28/12  00142 28/12  00143 28/12  00144 28/12  00145 28/12  00146 28/12  00147 28/12  00148 28/12  00068 11/12  00069 11/12  00070 11/12  00072 11/12 00075 11/12  00077 11/12  00078 11/12  00080 11/12  00081 11/12  00082 11/12  00083 11/12  00084 11/12  00088 11/12  00090 28/12  00096 28/12  00097 28/12  00100 28/12
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US (nationwide)
  • Descripción del producto
    Companion External Battery, Part Number: 293001-001 || The Companion External Battery is a component of the Companion 2 Driver System and the Companion Driver System. Both Driver Systems, with the temporary Total Artificial Heart (TAH-t) are indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure.
  • Manufacturer
    SynCardia Systems Inc.

Manufacturer

SynCardia Systems Inc.
  • Dirección del fabricante
    SynCardia Systems Inc., 1992 E Silverlake Rd, Tucson AZ 85713-3865
  • Empresa matriz del fabricante (2017)
    Tah Windown Inc.
  • Source
    USFDA