Events

Retiro De Equipo (Recall) de SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RESCUE 7 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
    102713
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-11-19
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Devices within these serial number ranges may be affected by one of both of these 2 identified. issue one: devices may intermittently or sometimes repeatedly switch themselves on and remain on for 10minutes which could eventually cause premature depletion of battery capacity. should this condition not be detected the battery may become depleted below a level where it could power the device to safely deliver therapy if required. issue two: the battery management software in affected devices may mis-interpret changes in voltage which occur during the normal operation of the device as indications of a low battery capacity. this can trigger an unnecessary low battery warning which if it occurs during an rescue event may cause the device to switch off and/or may delay the delivery of shock therapy.

Device

SAMARITAN PAD AUTOMATED EXTERNAL DEFIBRILLATOR(AED)- MAIN UNIT
  • Modelo / Serial
    Model Catalog: SAM-300 (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM-300 (Lot serial: 040000501 - 0700032917); Model Catalog: SAM-300 (Lot serial: 08A00035000 - 10A0070753); Model Catalog: SAM300P (Lot serial: 040000501 - 0700032917); Model Catalog: SAM300P (Lot serial: 10C00200000 - 10C00210106); Model Catalog: SAM300P (Lot serial: 08A00035000 - 10A0070753)
  • Descripción del producto
    samaritan PAD SAM 300/300P
  • Manufacturer
    RESCUE 7 INC.

Manufacturer

RESCUE 7 INC.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Rescue 7 Inc
  • Source
    HC