Events

Retiro De Equipo (Recall) de Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Physio-Control Australia Pty 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
    RC-2016-RN-01482-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-11
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01482-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Physio-control has become aware that the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value when using etco2 in the kpa or % setting mode and in a situation where the reading is above 9.9 kpa. although only 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 misinterpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment and/or delays in clinical decision making. there have been no reports of incorrect patient treatment or harm associated with this issue.
  • Acción
    Physio-Control is requesting users to:- 1. Forward this information to all associated sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator; 2. In the event staff use LIFEPAK 15 monitor/defibrillator to display EtCO2 values they should also display the EtCO2 waveform which includes the range along the right side of the display; 3. In the event staff use either kPa or % settings, they should activate EtCO2 alarms to identify EtCO2 values outside the normal range; and 4. If local protocols allow this option, consider changing the EtCO2 to measure in the mmHg setting. Once a permanent correction is developed Physio-Control will post information on our website when an updated software version is available.

Device

Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option

Manufacturer

Physio-Control Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA