Events

Retiro De Equipo (Recall) de LIFEPAK 15 MONITOR/DEFIBRILLATOR

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHYSIO-CONTROL CANADA SALES 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
    57989
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-09-08
  • 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
    Physio-control inc. lifepak 15 monitor/defibrillators with etco2 capability are distributed with the etco2 setting preset to display in mmhg. customers may choose to reconfigure the device to display the etco2 in alternative modes of kpa or % settings. when using etco2 in the kpa or % setting and in a situation where the reading is above 9.9 kpa the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value. although part of the first digit of the etco2 value is obscured by the respiratory rate the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient's etco2 value. clinical interpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment. there have been no reports of incorrect patient treatment or harm associated with this issue.

Device

LIFEPAK 15 MONITOR/DEFIBRILLATOR
  • Modelo / Serial
    Model Catalog: 99577-XXXXXX (Lot serial: > 1000 NUMBERS CONTACT MFG)
  • Descripción del producto
    LIFEPAK 15 MONITOR/DEFIBRILLATOR
  • Manufacturer
    PHYSIO-CONTROL CANADA SALES LTD

Manufacturer

PHYSIO-CONTROL CANADA SALES LTD
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC