Events

Alerta De Seguridad para Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class III. Products Affected: EPIQ 7 - Version 1.3.2 or lower with Pediatric Cardiology option. EPIQ 5-US814C0626 / US914C0627 / US914C0261 / USO14C0601 / USO14C0602 / USO14C0603 / USO14C0604 / USO14C0605 / USO14C0606 / US215C0175 / US215C0429 / US215C0430 / US215C0432 / US215C0432 / US215C0434 / US215C0434

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1576
  • Fecha
    2015-05-08
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    The conclusion of the risk analysis performed by the company was not acceptable for pediatric cardiology and acceptable for the rest of the applications. If a health care provider makes a clinical decision based on a calculated Cardiac Index using an incorrect BSA without considering other indicators of cardiac function, the result may be an incorrect diagnosis and / or delayed or incorrect therapy.
  • Causa
    When the epiq 5 and 7 ultrasound system is set to "metric" and the weight and / or height are reported, a unit conversion error may result in incorrect calculation of the body surface area (bsa) of the patient. when using only the patient's weight to calculate bsa, which is standard practice for patients below 2 years, the result would bring a very high value, by a factor of approximately 1.7. the cardiac index calculated using this value would be very low, by a factor of 1.7. an error of this magnitude may not be immediately detected by the user.
  • Acción
    The registry holder will perform a field correction of the equipment and advises users to verify that the version of the software used is affected. If you have an affected software version and the Pediatric option is enabled, contact your local Philips representative to schedule an update of your software. ////// Until your software can be updated, the situation can be avoided by ensuring that the "Patient Data Units" setting is set to "English" units. If this setting is not acceptable to your institution and you need to use the Metric units, you can avoid the problem by ensuring the following: 1. After turning on the system, open the Patient Data screen once before including a scan. This will put the Patient Data screen back in an appropriate status and the problem will not occur. 2. Ensure that the Patient Data screen is maintained on the Metric units instead of enabling the English units. If a height or weight value has to be reported in English units, then it must be converted to Metric manually to avoid the problem. Finally, ensuring that the Patient Data screen is using the Metric units before uploading the data of any examination will prevent the data from this examination from being changed.

Device

Ultrasound equipment for EPIQ diagnosis, EPIQ models 5 and 7. Registration: 10216710275. Class II...

Manufacturer

Philips Medical Systems Ltda.; Philips Medical Systems Nederland B.V.
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    ANVSANVISA