Events

Retiro De Equipo (Recall) de Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Welch Allyn Australia Pty Limited.

¿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-2013-RN-01124-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-11-08
  • 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-2013-RN-01124-1
  • 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
    Internal product testing conducted by welch allyn has identified fault conditions relating to electrical noise caused by proximal defibrillation activity that could, in rare instances, potentially interrupt propaq lt device operations. if this event were to occur, the device would either present an error screen instructing the user to restart the monitor, or could instead present a blank or white screen. either screen would be accompanied by one or more blinking led lights, and in either case, the issue would be resolved by restarting (power cycling) the monitor. this issue is more likely to occur at higher energies such as 5kv. there is no risk associated with this issue other than a very short delay in obtaining patient vital signs from the propaq lt while the device is restarted.
  • Acción
    Welch Allyn is providing work around instructions for users to follow if the error messages are displayed. A software update will be implemented to permanently correct the issue.

Device

Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)
  • Modelo / Serial
    Welch Allyn Propaq LT / Propaq 802 with Nellcor SpO2 (multifunction patient monitor)Model Numbers: 802LTAN, 802LT0NSerial Numbers: KA009946 to KA027084 and KL014918 to KL019440ARTG Number: 123809
  • Manufacturer
    Welch Allyn Australia Pty Limited

Manufacturer

Welch Allyn Australia Pty Limited