Events

Retiro De Equipo (Recall) de ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cable

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare 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-2018-RN-00241-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-03-26
  • 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-2018-RN-00241-1
  • 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
    Siemens has identified that in some cases the ecg signal may flatline due to electromagnetic interference when used in conjunction with electrosurgical equipment. the electrosurgical equipment creates electromagnetic interference (emi) which is then transmitted to the physio module and the sc2000 system through the aux in/out cable. this interference causes the system to lose communication with the physio module. to date, there have been no reported injuries as a result of this issue.
  • Acción
    Siemens is advising: If the ECG trace disappears or flatlines, perform the following steps to disable the ECG trace and exit the physio module functionality: 1. Press F13 (Physio) on the keyboard. 2. Press the scroll wheel to select the appropriate ECG or AUX trace option and then press the Off soft key. 3. To exit the Physio menu, press F13 (Physio) again. After these steps are performed, the ultrasound system will use time-based captures instead of beat captures. Also note that the system may be rebooted to reset the ECG trace. However, if the electrosurgery equipment is used again the symptom will reoccur. This issue will be resolved by a hardware update to affected systems. Siemens Customer Service will contact users to schedule this replacement if the system configuration is affected by the scope of this issue.

Device

ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware...
  • Modelo / Serial
    ACUSON SC2000 ultrasound with 5.0 software (VB20A, VB20B, or VB20C) and the ECG (physio) hardware and Auxiliary (AUX IN/OUT) cableCatalogue number: 10433816ARTG Number: 139591Siemens Healthcare - Ultrasound system, imaging, cardiovascular
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA