Events

Retiro De Equipo (Recall) de Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator

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 Osypka Medical 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
    56121
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2444-2010
  • Fecha de inicio del evento
    2010-06-30
  • Fecha de publicación del evento
    2010-09-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-08-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93070
  • 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
    pulse-generator, pacemaker, external - Product Code DTE
  • Causa
    The recall was initiated after osypka medical received two (2) complaints from their japanese distributor regarding an incompatibility of the pace 203h with some new types of 9 v batteries. the investigation revealed that pace 203h of a certain manufacturing period malfunction (i.E., not stimulate) when a type of 9 v batteries with higher than usual open circuit voltage (ocv) is used. failure t.
  • Acción
    OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical. If you have any questions call (858) 454-0021 or e-mail to mail@osypkamed.com

Device

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
  • Modelo / Serial
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution: USA including states of CA & FL
  • Descripción del producto
    St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator || The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
  • Manufacturer
    Osypka Medical Inc

Manufacturer

Osypka Medical Inc
  • Dirección del fabricante
    Osypka Medical Inc, 7855 Ivanhoe Ave Ste 226, La Jolla CA 92037-4561
  • Empresa matriz del fabricante (2017)
    Osypka Medical Inc
  • Source
    USFDA